Senior Quality Engineer - North Haven, CT

Senior Quality Engineer – Surgical Needles Manufacturing

Location:

North Haven, CT – 100% onsite. This role supports the Surgical Needles Manufacturing business within Medtronic’s Surgical Innovations group.

• Develop, modify, apply and maintain quality standards and protocols for processing materials into partially finished or finished 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; conduct quality assurance tests; perform statistical analysis to assess the cost of, and determine the responsibility for, products or materials that do not meet required standards and specifications.
• Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• Specialize in areas such as 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 a technical field with 4+ years of work experience in Engineering and/or Quality, OR Advanced degree in Engineering, Science or a technical field with 2+ years of work experience, OR PhD with 0 years of relevant experience.

• Bachelor’s degree in Engineering (Chemical, Biomedical, Mechanical, or related discipline); advanced degree preferred.
• Strong expertise in process validation across the full validation 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) to support 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 (medical device and/or pharmaceutical) with knowledge of CFR requirements, engineering drawings, and end‑to‑end manufacturing processes including machining, chemical processing, packaging, and sterilization.
• For degrees earned outside the United States, a credential that satisfies 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

The job requires independent mobility, use of a computer, and communication with peers and co‑workers. Reasonable accommodations may be provided for qualified individuals with disabilities.

Only candidates with unrestricted U.S. work authorization at the time of hire and for the duration of employment are considered for this role.

Salary: $98,400 – $147,600 (USD) for U.S. locations. Eligible for the Medtronic Incentive Plan (MIP). Benefits include Health, Dental, Vision insurance;
Health Savings Account;
Flexible Spending Account;
Life insurance;
Long‑term disability;
Dependent daycare spending account;
Tuition assistance; 401(k) with employer match; short‑term and long‑term disability; paid time off; paid holidays;
Employee Stock Purchase Plan;
Employee Assistance Program; additional benefits for senior positions.

Medtronic is an equal employment opportunity employer and provides reasonable accommodations for qualified individuals with disabilities.