Senior Quality Engineer

Senior Quality Engineer – North Haven, CT

Position within Medtronic’s Surgical Innovations group focused on ensuring the highest standards of quality and compliance in medical device manufacturing processes.

• Develop, modify, apply and maintain quality standards and protocols for processing materials into partially finished or finished products.
• 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; conduct quality assurance tests; and perform statistical analysis to assess the cost and determine responsibility for materials that do not meet required standards and specifications.
• Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in design, incoming material, production control, product evaluation and reliability, inventory control, or research and development as they apply to product or process quality.

• Bachelor’s Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality.
• Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality.
• PhD with 0 years relevant experience.

• Bachelor’s or advanced degree in engineering (chemical, biomedical, mechanical, or related discipline).
• Strong expertise in process validation across the full lifecycle, supporting complex manufacturing processes in regulated environments.
• Proven experience leading root cause investigations, CAPA development, and management of nonconforming material (NCMR) activities.
• Proficiency in statistical analysis and tools (e.g., Minitab) for data‑driven, risk‑based decision making and continuous improvement.
• Demonstrated ability to mentor engineers and collaborate effectively across cross‑functional teams.
• Experience in FDA‑regulated manufacturing with knowledge of CFR requirements, engineering drawings, and end‑to‑end manufacturing processes.
• For Baccalaureate degrees earned outside the United States, a degree that satisfies 8C.F.R. §214.2(h)(4)(iii)(A).

Applicants must possess unrestricted U.S. work authorization at the time of hire. U.S. work‑authorization sponsorship is offered exclusively for principal-level roles and above.

Salary range: $98,400 – $147,600 (USD). Eligible for short‑term incentive (Medtronic Incentive Plan). Benefits include health, dental, vision insurance; health savings and flexible spending accounts; life insurance; disability leave; dependent daycare account; tuition assistance; 401(k) with employer match; paid time off; and other standard employee benefits.

Medtronic provides equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, disability, race, religion, creed, gender, sex, sexual orientation, gender identity, genetic information, marital status, public‑assistance status, veteran status, or any other characteristic protected by law. Medtronic will provide reasonable accommodations for qualified individuals with disabilities.