JOB SUMMARY:The Manufacturing Engineer will lead the transition of new products from Development into sustained Manufacturing and support products through the lifecycle. Apply Engineering principles to analyze, develop and implement Engineering Change Orders and/or Deviations to document all changes to production process, tools or parts in accordance with GMP and ISO quality requirements.ESSENTIAL FUNCTIONS:• Develop, implement, and maintain methods, operation sequence and processes related to the manufacturing of parts, components, sub-assemblies, and final assemblies• Work on problems of moderate scope where analysis of product, process, and/or data requires an identification and gathering of relevant factors• Design and construct or specify and purchase electrical, mechanical and/or software tools and fixtures for performing various tasks in a safe, efficient, repeatable and cost-effective manner. Perform tooling qualification.• Continuously and proactively seek cost reduction opportunities without compromising quality or on-time delivery• Responsible for leading troubleshooting efforts/technical teams to perform root cause analysis and subsequent solution development of process, vendor or design related problems associated with supporting a product• Identify and propose tooling enhancements and/or develop the solution• Familiar with automated test processes used at PCBA suppliers and be able to specify which types of testing are required for any given PCBA.• Identify and qualify new components to replace obsolete components• Analyze the disposition of non-conforming parts• Track all problem parts for a product and develop and report action plan• Estimate manufacturing costs and determines time standards• Work cross functionally to support the development of new products that are manufacturableREQUIREMENTS:• BS degree in engineering discipline (EE,ME,SW,CS) or related field• Two (2) years equivalent experience in design or manufacturing engineering OR MS degree in engineering discipline or related field.• Experience with medical device manufacturing and optics assembly desirable• Familiar with DFT, GMP, and ISO 9001• Proficient with MS Word, Excel, Powerpoint• Proficiency with Mentor Graphics a plus• Proficiency with Solidworks desirableThe annual pay range for this position is $84,000 -$105,000 .The pay offered for this role may be influenced by factors such as job location, scope of role, qualifications, education, experience, & complexity/specialization/scarcity of talent.This position is also eligible for a performance bonus. ZEISS also offers robust benefits, including medical plans, retirement savings plan and paid time off.Your ZEISS Recruiting Team:Jo Anne MittelmanZeiss provides Equal Employment Opportunity without unlawful regard to an Applicants race, color, religion, creed, sex, gender, marital status, age, national origin or ancestry, physical or mental disability, medical condition, military or veteran status, citizen status, sexual orientation, pregnancy (includes childbirth, breastfeeding or related medical condition), genetic predisposition, carrier status, gender expression or identity, including transgender identity, or any other class or characteristic protected by federal, state, or local law of the employee (or the people with whom the employee associates, including relatives and friends).

Senior Design Engineer

Career Management Group, Dublin

Join Our Team as a Senior Quality Design Engineer!Are you passionate about ensuring products meet the highest standards of quality and design excellence? Do you thrive in a dynamic environment where innovation is key? Career Management Group is partnered with a leading company that manufactures and distributes medical equipment serving the respiratory, sleep and cardiology patients, caregivers, physicians, and providers. We are looking for a talented Senior Quality Design Engineer to join our team and play a pivotal role in driving quality assurance initiatives from conception to implementation.We're dedicated to pushing the boundaries of what's possible, creating products that make a real difference in people's lives. As a Senior Quality Design Engineer, you'll be at the forefront of this mission, working collaboratively with cross-functional teams to develop and maintain rigorous quality standards throughout the product lifecycle.Qualifications: 7+ years of experience or equivalent experience in Medical Device Design control and the application of ISO14971, 21CFR820, ISO13485, IEC62304, IEC 62366, IEC 60601.Experience with new design (NPD), design transfer, design changes and sustaining of mechanical and software driven devices.Experience with test method development and the validation of those test methods.Experience with risk management file creation and updates.Bachelor's degree in engineering, life sciences or related field.Preferred Education:Master's degree in engineering or life sciences discipline. Preferred Experience:Experience working with electronic circuit boards and cable assemblies.DHF (Design History File) remediation when moving from one design control system to another.EUMDR (European Medical Device Regulation).Design for Six Sigma.House of Quality.Familiarity with electronic quality management systems.Excellent written/oral communication skills required. Must be able to work effectively with diverse groups of people.Duties and Essential Functions:Each Employee consistently demonstrates the following essential functions:Initiate, review and/or approve Engineering Change Orders.Perform and document design controls for new products.Develop and maintain risk management files.Support specification development.Identify and implement improvements to the design control program.Coordinate and perform test method validation testing.Support verification and validation testing.Applies statistics to make business decisions. Ability to conduct failure investigation and root cause analysis.Identify and implement improvements to QMS.May support internal audits to verify compliance with procedures.Participate in, and support of, external regulatory audits and inspections.Attends and participates in departmental meetings.Attends seminars and training sessions necessary to maintain appropriate level of professional competence.Ensures all department compliance guidelines are met.Attends all meetings, in-services training, or continuing education as delegated by the supervisor. Provides customer focused interactions.Performs all duties necessary for the department as per department policies and procedures.Performs other duties and responsibilities as delegated by the supervisor within the scope of practice and the responsibilities in the department. Why Join Us?Opportunity to work on cutting-edge projects and make a real impact.Dynamic and collaborative work environment where your ideas are valued.Competitive compensation package and comprehensive benefits.Career development and growth opportunities.Potential performance-based bonus and/or signing bonus.If you're ready to take your career to the next level and make a meaningful contribution to our team, we'd love to hear from you! Apply now to join us as a Senior Quality Design Engineer and help shape the future of our products.