Principal Quality Engineer - North Haven, CT

Medtronic • North Haven, CT

1d • Onsite

About The Position

We anticipate the application window for this opening will close on - 2 Apr 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. We are seeking a Senior Quality Systems Specialist to join our team in Mystic, 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.

Requirements

• Requires a Baccalaureate degree and minimum of 7 years of relevant experience OR Master's degree with a minimum of 5 years relevant experience OR PhD with 3 years relevant experience.
• 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.

Nice To Haves

• Bachelor’s degree in Engineering (Chemical, Biomedical, Mechanical, or related discipline); advanced degree preferred
• Recognized Subject Matter Expert (SME) in process validation, providing technical leadership across the full validation lifecycle and complex manufacturing processes.
• Extensive experience leading advanced root cause investigations, including CAPA strategy development and oversight of Nonconforming Material Reports (NCMR).
• Advanced proficiency in statistical analysis and application of statistical tools to drive risk‑based decision making and continuous improvement.
• Demonstrated ability to mentor, coach, and influence engineers and cross‑functional teams, serving as a technical authority within the organization.
• Strong working knowledge of Minitab or equivalent statistical software for complex data analysis.
• Expert ability to read, interpret, and apply engineering drawings, including equipment (EQ), tooling, and product specifications.
• Significant experience in FDA‑regulated environments (medical device and/or pharmaceutical), with deep understanding of CFR requirements and quality system regulations..
• Broad manufacturing experience supporting mechanical (machine shop), chemical, finished goods, packaging, and sterilization processes, with the ability to assess quality risk across end‑to-end manufacturing systems.

Responsibilities

• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensures 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.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
• Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees