Senior Quality Engineer

Senior Quality Engineer

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.

This position will support the Surgical Sutures 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. A key requirement of this role is deep expertise in process validation across the full validation lifecycle, with the ability to support complex manufacturing processes in highly regulated environments.

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

• 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 outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 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 or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

U.S. Work Authorization & Sponsorship

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the…