Product Support Engineer Salary in Danvers, MA

Careers that Change LivesA career at Medtronic is like no other. We're purposeful. We're committed. And we're driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.In this exciting role as a Quality Engineer II, you will have responsibility for providing comprehensive manufacturing quality support for commercial medical devices in the area of component manufacturing. This includes activities related to test method validation, process validation, inspection improvements, and process/quality change initiatives. This is an onsite role at the Danvers, MA location. A Day in the Life Responsibilities may include the following and other duties may be assigned. Provide Quality Engineering support for commercial medical device products. Develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product. Collaborate with engineering and manufacturing functions to ensure quality standards are in place. Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Design or specify inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. Apply knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing. Ensure changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements. Present technical data to groups within and outside the organization. Utilize quality tools to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root case analysis, reading and correcting drawings. Must Have: Minimum Requirements Bachelor's Degree in Engineering, Science or technical field with 0+ years of work experience in Engineering and/or Quality Nice to Have Medical Device Master's degree Manufacturing Experience Green Belt Six Sigma/DRM Training/Certification ASQ-CQE, CQA, CBA or equivalent certifications SAP QM or SPC Software Experience Effective verbal and written communication, analytical, influencing and interpersonal skills Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), JPAL, and ISO 13485:2016 Demonstrated working knowledge of process validation, statistical methods, risk management About MedtronicTogether, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.Physical Job RequirementsThe physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here .This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here .The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

Ca reers that Change Lives - onsite at Danvers, MA location Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It's no accident - we work hard to cultivate a workforce that reflects our patients and partners. We believe it's the only way to drive healthcare forward and remain a global leader in medical technology and solutions. Danvers, the trusted partner for development and scaling of leading-edge delivery systems, transforming pellets into unparalleled performance and enabling Medtronic to serve more patients worldwideA Day in the LifeBe a part of a dynamic team that designs and develops manufacturing processes for new delivery systems from concept through design transfer and product launch. This process development team is committed and driven in our mission to revolutionize the way we manufacture delivery systems while producing a high-quality product for our patients and customers.The ideal candidate will be a seasoned professional with a passion for advanced manufacturing and the development of manufacturing processes during product development phases. The candidate will be involved with process development, setting up manufacturing operations, and interfacing cross-functionally with other key engineering expertise to develop a product.In this role, you will part of a team but will be able to work independently with limited supervision to determine and develop approaches to solutions. You will coach and review the work of lower-level professionals. You may manage projects/processes. You will communicate with senior internal and external customers and suppliers. Your work will involve collaboration and dynamic interactions with R&D and Design Assurance regarding products in the development pipeline and with operation team members for new or iterative product implementation. Problems and issues faced are difficult and may require understanding of multiple issues, job areas or specialties.Responsibilities may include the following and other duties may be assigned:Process Technologies: Lead the exploration and development of new process technologies that may be incorporated into new product development projects or existing manufacturing lines. Analysis provided is in-depth in nature and often provides recommendations on process improvements. Process Development : Lead new product development by designing and developing manufacturing processes for new products that facilitate ease of manufacturing while producing quality, cost effective products with optimized yields. Such activities include, but are not limited to, the following:• Manufacturing Studies: Work with engineering team on studies to characterize process inputs to drive development of critical manufacturing/process specifications that are both robust and meet quality expectations Use appropriate statistical support and Design of Experiments (DOE).• Equipment and Fixture Development: Identify equipment and fixture needs within pilot line and/or manufacturing operations. • Documentation: Generate required documentation in support of manufacturing products and processes. These include engineering protocols/reports, PFMECAs and manufacturing instructions. Ensure compliance with internal procedures, GMP and regulations. • Qualification and Validation: Generate and execute plans for equipment qualification and process validation. Lead test method development and validation where needed.Responsibilities may include the following and other duties may be assigned. Provides technical and sustaining engineering support in a manufacturing area. Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products. Integrates equipment and material capabilities to meet process module target specifications and technology target specifications. Reviews product development requirements for compatibility with processing methods to determine costs and schedules. Interacts with product design and development personnel to ensure that processes and designs are compatible. May develop and conduct statistical analysis or recommend additions to document work. Leads the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations. This can include scouting and feasibility work, material selection, process and equipment selection, tooling / fixture and equipment installation and assessment of inputs, outputs and alignment to requirements. Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems. Ensures processes and procedures are in compliance with regulations. Must Have: Minimum Requirements Bachelors degree required Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience Nice to Have• Previous medical device experience• Demonstrated problem-solving and critical thinking experience• Solid oral and written communication skills, including presentation skills• Solid interpersonal skills and ability to work in a cross-functional team environment• Solid understanding of statistical techniques and analysis• Design for Reliability and Manufacturability (DRM) experience.• Demonstrated computer skills such as Minitab, Excel, Word and Project.• Process Validation (IQ/OQ/PQ) and Test Method Validation experience.About MedtronicTogether, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.Physical Job RequirementsThe physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here .This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) on page 6 here .The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.

Coordinate the management process for product escapes, identifying root causes and implementing corrective/preventive actions.Facilitate and coach cross-functional Problem Resolution Teams for product escapes and assist in high-impact organizational issues.Maintain cooperative relationships with all departments, customers, and suppliers, leveraging problem-solving interactions across the enterprise.Coordinate, track, and manage RMA processes to completion.Generate, maintain, and provide quality metrics to the management team, overseeing quality improvement programs.Drive continuous improvement initiatives using data and KPIs.Provide technical support and maintain strong working relationships with the operations team.Investigate and analyze hardware/assembly issues affecting quality and delivery, reviewing procedures, specifications, instructions, processes, and equipment to ensure compliance and resolve concerns.Build cross-departmental relations to effectively communicate the status of parts.Process MRB parts under review.MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.Expertise in RCCA tools with strong capability in executing robust systemic RCCA.Proficient in interpreting and understanding engineering technical data, including manufacturing and part drawings, to guide cross-functional teams.Extensive experience in managing Quality Management Systems and using MRP/ERP/SAP systems for production control, planning, manufacturing execution, clinic, and MRB.Resilient in handling challenging situations, consistently finding ways to achieve desired outcomes.Proven ability to interface effectively with all management levels, customers, and government agencies.Knowledgeable in aerospace quality standards, including AS9100, AS9102, and ISO.US citizenship required for government contracts.Preferred qualification: Certified 6 Sigma Blackbelt or equivalent.

Careers that Change Lives Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It's no accident - we work hard to cultivate a workforce that reflects our patients and partners. We believe it's the only way to drive healthcare forward and remain a global leader in medical technology and solutions. Danvers, the trusted partner for development and scaling of leading-edge delivery systems, transforming pellets into unparalleled performance and enabling Medtronic to serve more patients worldwide.A Day in the LifeMedtronic is currently searching for a Principal Process Development Engineer to join our growing team. In this exciting role in the Danvers facility, you will have responsibility for supporting the manufacturing of high-quality and complex delivery systems.As the Principal Process Development Engineer, you will:• Recommend and implement equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for new product development and post-market.• Integrate equipment and material capabilities to meet process module target specifications and technology target specifications.• Review product development requirements for compatibility with processing methods to determine costs and schedules.• Interact with product design and product development personnel to ensure that processes and designs are safe, ergonomic, repeatable, and scalable.• Develop and conduct statistical analysis or recommend additions to document work.• Lead the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations.• This can include scouting and feasibility work, material selection, process and equipment selection, tooling / fixture and equipment installation and assessment of inputs, outputs and alignment to requirements.• Develop manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems.• Ensure processes and procedures are in compliance with regulations.• Create, manage, and lead projects as assigned.Must Have: Minimum Requirements Bachelors degree required Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience Nice to Have 5 years of medical device experience Fixture and tooling experience. Experience leading complex projects. Start-up experience. Lean Six Sigma certification. Design for Reliability and Manufacturability (DRM) experience. IQ, OQ, and PQ experience. About MedtronicTogether, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.Physical Job RequirementsThe physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

In the role of Senior Quality Engineer at our Danvers, MA production site, you hold a pivotal position in the success of the Quality and Manufacturing organizations. Your main responsibilities include:Acting as a steward for product and process quality, offering expertise in the evaluation of change control for Mobius products at Danvers and across various sitesLeading and overseeing product quality investigations in collaboration with R&D, Manufacturing, Validation, and plant engineering, guaranteeing thorough root cause analysis, impact and risk assessment, and the implementation of corrective actionsSupporting process improvement activities with specific focus on right first-time quality metrics, including reduction in non-conformances, reworks, and customer complaintsLeading the execution of Organization Level Agreements, including quality commitments and quality improvement projects, and collaborating with stakeholders and project teams to ensure successful implementationOffering guidance, support, and technical expertise to assist other team members in achieving success Weekday Shift: Monday-Friday Who You Are:Minimum qualificationsAssociate's degree in engineering, applied engineering, sciences or related fieldMinimum of 3 years of relevant and progressive work experience Preferred Qualifications:Bachelor's degree in engineering, applied engineering, sciences, or related fieldStrong people leadership, project management, and problem-solving skills with a proven track record of prioritization and change managementBasic understanding of material analysis tools and techniques i.e., FTIR, DSC Calorimetry, microscopy, particle counters, and integrity testing by pressure decayDetailed understanding of equipment and process validation and qualification in a regulated industry including associated toolkits i.e., p/dFMEA, statistical process control, sampling plansUnderstanding of investigations, impact assessment workflow in a regulated environment subject to time constraints. An understanding of change control process in a regulated industryLean Six Sigma and/or root cause analysis trainingExperience with Quality Systems (e.g., Deviation, CAPA, Change Control, Documentation Management)Proven track record of working collaboratively and communicating successfully in a cross-functional and multi-cultural environmentDemonstrate strong quality knowledge: GMP/GDP, ISO standardsAbility to adapt and thrive in a constantly changing business environmentProficient in computer skills pertaining to MS Word, MS Excel, MS PowerPoint, MS Teams, MS SharePoint to support data review, analysis and sharing

Careers that Change LivesA career at Medtronic is like no other. We are looking for a Sr. Supplier Quality Engineer who will be a part of our Global Supplier Quality team. You will be driven by our mission to alleviate pain, restore health and extend life for millions of people worldwide and always 'Put Patient First'.You can grow your career with us; we hope you'll consider joining our team!A Day in the Life Responsibilities may include the following and other duties may be assigned. Ensures that suppliers deliver quality parts, materials, and services Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods Root cause investigation and Supplier CAPA management. Must Have: Minimum Requirements Bachelor's Degree and 4+ years of Supplier Quality Engineering experience OR advanced degree and 2+ years of experience Nice to Have Experience in fast paced environment. Problem solving skills. ASQ CSQP and/or CQE certification. Strong experience working across an organization using written and verbal skills to communicate and understand cross functional teams, interactions and responsibilities. Experience working in an FDA regulated manufacturing environment About MedtronicTogether, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.Physical Job RequirementsThe physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America) Travel: Yes, A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here .This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here .The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

We are seeking an experienced Sr. Operational Technology Engineer to join our Mobius Engineering Automation Team in Danvers, MA. As the Sr. Operational Technology Engineer, you will be part of the Mobius Engineering Automation Team and responsible to design, qualify, deliver, and maintain process control systems for manufacturing and laboratory operations with a focus on automation equipment development, implementation, and validation to join our Mobius Engineering Automation Team in Danvers, MA. Mobius Engineering is focused on the production of single-use biopharmaceuticals assemblies. This position is primarily responsible for providing innovative automated solutions to existing manual processes through collaboration with equipment suppliers and internal colleagues. This individual will be the point of contact for all plant-related projects and incidents from an OT perspective. This role will also be a key contributor to the design and implementation of the automation and direct control (DCS) or SCADA environment at the site. Key Responsibilities:Act as system owner and subject matter expert for a collection of systems managed at the siteAutomation Network and Infrastructure / ISA95 Human-Machine Interfaces (HMIs/control consoles)Data Historian (OSIPI) Lead systems maintenance (Inc. patch management, system updates), respectively build and secure dedicated expertise, while optimally coordinating and executing key support for update, incident and change management Define the systems lifecycle strategy, together with stakeholders and external maintenance partnersEnsure compliance with applicable prevention, quality and documentation good practices and procedures.Support Automation Project Engineers in various projects by making sure there is a strong connection to the operational environment and all proper handover preparations into post-project operationResponsible for maintaining vendor relationship through technology lifecycle to ensure minimal disruption to business operations, version upgrades, obsolecense, and service bulletinsResponsible for managing team in project definition, budgeting, planning and implementation phases, when needed.Contribute to Technical Risk Reviews (TRR) for projects in your respective district that involve ICT/Networking/Cyber SecuritySite OT systems typically consist of the central manufacturing and laboratory process control systems, data historian, equipment PLC/SCADAs and interfaces to PIM-, LIM- or Manufacturing Intelligence systems.Interface, maintain communication and collaborate with local and global IT organizations for IT owned systems and applications revision and upgrades that support the manufacturing and laboratory operations on site. Develop equipment documentation to meet GMP requirements, i.e.: URS, FAT, Equipment IQ/OQ/PQ, PM, SOPs. Perform IQ/OQ/PQ and provide maintenance support on instruments as needed.Utilize a strong understanding of PLC programming, Networking, electrical and controls systems to ensure the operability of existing production machines (PLC-Based, Rockwell), and to build the control systems for new machines. The candidate must be able to create PLC programs or make changes to existing programs to accomplish this function.Critically review and analyze sub-supplier's deliverables (Codes, Schematics, and Documentations).Create and manage network topology and I/O lists.Provide guidance for the safe installation, maintenance and troubleshooting of electrical control systems, including components of machinery and equipment.Observe all regulatory requirements GMP's, ISO, internal policies. Detailed knowledge of NFPA 79, ISO 13849-1, ANSI-95 is highly preferred.Observe and implement Configuration Management Principles to maintain the validated state of existing validated automated manufacturing equipment.Act as the subject matter expert for all automation activities (Change control, validation, etc.).International Travel up to 10-20% as need for this role.This individual requires to be onsite, and this is not a remote position. Who You Are:Minimum Qualifications:Bachelors Degree in any engineering discipline is required. 5+ years of experience in definition, design, development and implementation of production control systems for advanced technology facilities, OT system design and project execution of digitalization projectsAdvanced knowledge in OT systems and orchestration such as DCS, PLC, HMI, Data Historians, MES/EBR, Batch Systems, LIMS or any similar systemHands on experience in diagnosis, maintenance, installation and setup of OT systems hardware and software Preferred Qualifications:PLC Programming, Motion Control and HMI experience (AB PLCs and Rockwell Software products)Experience in a commercial medical, biotechnology, Bio-pharmaceutical, pharmaceuticals, life sciences manufacturing environment is highly preferred.In depth knowledge of Rockwell Software packages or similar system is highly preferred (Transaction Manager, Metrics, Asset Center, etc.)Able to self-direct toward individual milestones as part of team projects with a strong sense of responsibility, urgency, and high energy with a positive behavior.Strong communication and interpersonal skills, ability to collaborate across disciplines.Highly motivated, adaptable, and self-directed.Strong communication and organizational skills.Ability to work with other site, cross functional teams and to collaborate and work with Global Life Sciences OT and Operations team.Knowldege of implementing layers of protection for cyber security, OT and ITAdvanced knowledge in OT infrastructure design, software engineering and IT security

Careers that Change Lives Engineers create our market-leading portfolio of innovations. Join us to make a lasting impact. Help bring the next generation of life-changing medical technology to patients worldwide.Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.The Danvers Site Brings Multiple business units together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. A Day in the Life Responsibilities may include the following and other duties may be assigned.The go to person at site level for everything related to Manufacturing Execution System (MES). Overall, the Site MES Owner plays a critical role in ensuring the successful deployment, operation, and optimization of the MES system at the manufacturing site, ultimately contributing to improved efficiency, productivity, and quality within the organization.• Working closely with stakeholders across different departments to gather and document requirements for the MES system. This includes understanding business needs, user requirements, and technical specifications to ensure alignment with site-specific objectives.• System Configuration and Customization: Overseeing the configuration and customization of the MES system to meet site-specific requirements. This may involve defining workflows, configuring user interfaces, and integrating with other systems and equipment within the manufacturing environment.• Validation Documentation: Complete the maintenance plan and report. Review and approve scenarios, as well as conduct regression testing. Load and review user acceptance testing results into the QMS for validation. 3• User Training and Adoption: Ensuring that site personnel are adequately trained on using the MES system effectively. This includes developing training programs, conducting user training sessions, and providing ongoing support to facilitate smooth adoption of the system. May incorporate inspection and test requirements into the production plan.• Performance Monitoring and Optimization: Monitoring the performance of the MES system to ensure that it meets site objectives for productivity, efficiency, and quality. This involves analyzing system metrics, identifying areas for optimization, and implementing improvements to enhance system performance.• Compliance and Regulatory Requirements: Ensuring that the MES system complies with relevant industry standards, regulations, and quality management requirements. This may involve conducting audits, maintaining documentation, and implementing controls to ensure regulatory compliance.• Change Management: Facilitating change management processes associated with the MES deployment, including communicating changes and key decisions to site personnel, addressing concerns, and promoting acceptance of the new system.• Continuous Improvement: Driving continuous improvement initiatives to optimize the use of the MES system and maximize its value to the organization.• Stakeholder Communication: Serving as the primary point of contact for communication and coordination between stakeholders involved in the MES deployment. This includes providing regular updates, facilitating meetings, and addressing concerns raised by stakeholders.• Driving standardization: relating to MES System and business processes• Template Design Input: Aligning with other global plant deployment teams to drive standardization relating to MES system and business processes.• Provides guidance to MES engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.Must Have: Minimum Requirements Bachelors degree required Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience Nice to Have• Strong expertise of current manufacturing processes, information flows, material flows, production flows, critical data collection points• Ideally MES experience gained in previous deployments• Strong computer literacy and passionate about digitalization• Experience in Microsoft office tools like PowerPoint / Visio• Experience with designing or manufacturing disposable medical devices• Experience with polymer processing• Experience working in a medical device company quality system• Experience with statistical analysis (sample size determination, DOE, Tolerance Intervals, SPC)• Experience with problem solving methodology and tools (DMAIC)• Practical knowledge of project managementAbout MedtronicTogether, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.Physical Job RequirementsThe physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here .This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here .The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

Careers that Change Lives - onsite daily at our Danvers facilityThis position is a key role at site level at start, during and post deployment of the MES system, the role requires strong manufacturing process knowledge combined with industrial data and Operational Technology knowledge. This is a hands-on role and requires deep knowledge of the MES system. The aim of the role is to assure local ownership of the MES system with the objective to become self-sustaining. The MES owner is the core site experts that assures smooth transition of current as-is process to future to-be processes according to GxP.A Day in the LifeResponsibilities may include the following and other duties may be assigned.The go to person at site level for everything related to Manufacturing Execution System (MES). Overall, the Site MES Owner plays a critical role in ensuring the successful deployment, operation, and optimization of the MES system at the manufacturing site, ultimately contributing to improved efficiency, productivity, and quality within the organization.Facilitates collaboration between Core and Deployment Teams. Obtains formal acceptance/sign-off when necessary.Working closely with stakeholders across different departments to gather and document requirements for the MES system. This includes understanding business needs, user requirements, and technical specifications to ensure alignment with site-specific objectives.Overseeing the configuration and customization of the MES system to meet site-specific requirements. This may involve defining workflows, configuring user interfaces, and integrating with other systems and equipment within the manufacturing environment.Complete the maintenance plan and report. Review and approve scenarios, as well as conduct regression testing. Load and review user acceptance testing results into the QMS for validation. 3Ensuring that site personnel are adequately trained on using the MES system effectively. This includes developing training programs, conducting user training sessions, and providing ongoing support to facilitate smooth adoption of the system.Monitoring the performance of the MES system to ensure that it meets site objectives for productivity, efficiency, and quality. This involves analyzing system metrics, identifying areas for optimization, and implementing improvements to enhance system performance.Ensuring that the MES system complies with relevant industry standards, regulations, and quality management requirements. This may involve conducting audits, maintaining documentation, and implementing controls to ensure regulatory compliance.Facilitating change management processes associated with the MES deployment, including communicating changes and key decisions to site personnel, addressing concerns, and promoting acceptance of the new system.Driving continuous improvement initiatives to optimize the use of the MES system and maximize its value to the organization.Serving as the primary point of contact for communication and coordination between stakeholders involved in the MES deployment. This includes providing regular updates, facilitating meetings, and addressing concerns raised by stakeholders.Driving standardization relating to MES System and business processesAligning with other global plant deployment teams to drive standardization relating to MES system and business processes.Must Have: Minimum Requirements Bachelors degree required Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience Nice to HaveStrong expertise of current manufacturing processes, information flows, material flows, production flows, critical data collection pointsIdeally MES experience gained in previous deployments.Strong computer literacy and passionate about digitalizationExperience in Microsoft office tools like powerpoint / visioProject management skillsCommunication and influence skillsWritten communication skillsPresentation skillsKnowledge of product development, manufacturing, clinical, regulatory and business management requirementsPC skills; word processing, project management, and spreadsheet software.Knowledge of medical device industryMacintosh, Microsoft word and project management and ExcelExperience leading project teams7+ years technical experience in a manufacturing industry with BS or 5+ years technical experience in a manufacturing industry with MSProject management experienceMBA or MS in engineeringAbout MedtronicTogether, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.Physical Job RequirementsThe physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

As a member of the Mechanical Assembly Technologies team your role is to scout, develop and deploy new technologies in support of higher performance within our manufacturing operations. Support major capital projects through technology assessments and technology deployment and work with our manufacturing customers to assess their current processes for technology and automation improvement opportunities. Products of focus are membrane-based filtration devices and single use assemblies produced across our global network with key locations in Danvers, MA, Jaffrey, NH, Molsheim, FR and Cork IRE. Responsibilities:Working with our partners in the manufacturing sites, scout and validate technology-based opportunities for COGs improvement, quality improvements, throughput increases, safety risk reduction and Environmental impact reduction. For top opportunities, take ownership for technology options analysis and presentation.Working with site leaders, prepare business case documents for top improvement opportunities and build consensus among decision makers for project initiation and funding.Present project business cases to Capex Funding CommitteesDeploy new mechanical and automation technologies on "first-use" projects.Track project progress and spending as needed and prepare project updates. Proactively scout new technologies in adjacent industries, suggest deeper investigations into promising candidates, perform trials or proofs of concept where applicable.Share ideas, research and completed projects with colleagues doing similar work across the community of practice. Who You Are:Minimum Qualifications:Bachelors degree in Mechanical or Electrical Engineering or closely related field10 or more years of experience in a manufacturing, equipment or automation field Passion for technology exploration and development with proven track record of success in practical applications.Broad Engineering "toolbox" of skills such as mechanical design, machine controls, industrial robotics, machine vision, motion control and system integration.Candidate must be able to work, daily, from one of our centers of excellence in Danvers, MA, Molsheim, France or Jaffrey, NH. Preferred Qualifications:Masters degree in Mechanical or Electrical Engineering7+ years of hands-on experience in a manufacturing environment.Project management capabilities including user requirements creation, project status and budget tracking, vendor and stakeholder management."Future thinker" with ability to see larger business perspectives and ability to develop strategies to deploy technology in a pragmatic way.Collaborative team player with ability to communicate ideas effectively with good listening skills. Preferred Location: Danvers, MAAdditional Locations: Jaffrey, NH or Molsheim, France