Senior Quality Engineer - North Haven, CT

We anticipate the application window for this opening will close on - 1 Jun 2026

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way. That's the Medtronic Mindset - our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives.

This position will support the Surgical Needles' Manufacturing business within Medtronic's Surgical Innovations group located in North Haven, CT. We are seeking a Senior Quality Engineer to join our team in North Haven, CT. This role is integral to ensuring the highest standards of quality and compliance in our medical device manufacturing processes. As a key member of our Quality team, you will collaborate cross-functionally to enhance product reliability, optimize processes, and uphold regulatory compliance.

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We're working 5 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role is 100% onsite at our North Haven, CT manufacturing site.

Responsibilities may include the following and other duties may be assigned.

* 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; conduct quality assurance tests; and 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.

* 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.

Must Have:

Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.

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

Nice to Have

* 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 working knowledge of CFR requirements, engineering drawings, and end-to-end manufacturing processes including machining, chemical processing, packaging, and sterilization.

For Baccalaureate degrees earned…