Quality Engineer II

Medtronic • North Haven, CT

18d • Onsite

About The Position

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. Join Medtronic’s Advanced Surgical Instruments team and help engineer the quality behind life-changing technologies that impact patients worldwide. As a Quality Engineer II based in North Haven, CT , you will support the Access, Instrumentation, and Powered Focus Factory at a site known for its advanced manufacturing and collaborative, high-performing culture. This role is ideal for a detail-oriented, data-driven professional who thrives in a fast-paced environment and is passionate about driving excellence in product quality, patient safety, and continuous improvement. As a Quality Engineer II in the Advanced Surgical Instruments business, this role provides quality engineering support for the Access, Instrumentation, and Powered Focus Factory. They will partner with manufacturing, process engineering, and cross‑functional teams to ensure our surgical instruments consistently meet Medtronic quality standards, regulatory requirements, and patient safety expectations. This role monitors process performance and yields, leads nonconformance investigations and CAPAs, and supports validation and change control for new and existing products and processes. This role provides day‑to‑day floor support in the focus factory, drives use of data and quality tools to reduce defects and complaints and helps prepare for and participate in internal and external audits. They will also coach operators and engineers on quality system requirements and champions a culture of continuous improvement, compliance, and flawless execution within Advanced Surgical Instruments. 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 a minimum of 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. It is 100% onsite at our North Haven, CT manufacturing site.

Requirements

• Bachelor’s Degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field with 0+ years of work experience in Engineering and/or Quality
• 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.
• Possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Nice To Haves

• Experience leading root cause investigations and CAPA (Corrective and Preventive Action) activities
• Experience working in fast-paced, regulated manufacturing environments
• Process validation experience (IQ, OQ, TMV, PQ)
• Familiarity with statistical methods (SPC, trend analysis, sampling plans) and tools such as Minitab
• Six Sigma training or certification
• Experience supporting internal and external audits
• Working knowledge of ISO 13485, FDA QSR, and other applicable regulatory standards

Responsibilities

• Provide day-to-day quality engineering support on the manufacturing floor, partnering with operators, supervisors, and engineers to ensure adherence to procedures and immediate resolution of quality issues.
• Collaborate with manufacturing, operations, and cross-functional teams to ensure compliance with Medtronic Quality System requirements, regulatory standards, and internal procedures.
• Lead and support root cause investigations, nonconformance management, and Corrective and Preventive Actions (CAPA), ensuring timely, thorough, and compliant resolution of issues.
• Develop, implement, and maintain inspection and testing methods to ensure product quality and process consistency.
• Utilize statistical methods and data analysis to monitor process performance, identify trends, and drive continuous improvement in yield and defect reduction.
• Apply and reinforce a culture of continuous improvement, compliance, and accountability to support safe, effective, and reliable product output.

Benefits

• 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
• 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)
• 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