Quality Engineer II (Stapling Product Portfolio)

Medtronic • North Haven, CT

2d • 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 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 4 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. The Surgical Operating Unit (OU) at Medtronic is dedicated to advancing minimally invasive therapies that help improve patient outcomes and transform surgical care. The OU develops innovative technologies across surgical energy, stapling, advanced instrumentation, and robotics, enabling surgeons to operate with greater precision, efficiency, and confidence. By combining deep clinical insight, engineering excellence, and a strong focus on customer and patient needs, the Surgical OU plays a critical role in Medtronic’s mission to alleviate pain, restore health, and extend life. Medtronic is seeking a Quality Engineer II to support the Core Surgical Innovations (CSI) Stapling product portfolio within the Medical Surgical Operating Unit. This role plays a critical part in ensuring the quality, safety, and reliability of released medical devices across their full lifecycle—from design and manufacturing through distribution and product obsolescence. The Quality Engineer II will work on complex, parallel initiatives that have a direct and immediate impact on product quality, patient safety, and business performance. The role requires strong technical judgment, critical thinking, and collaboration with cross‑functional partners to support continuous improvement, product and process changes, and the resolution of quality issues.

Requirements

• Bachelor’s degree in Engineering or a related technical discipline, plus 2 years of relevant quality, engineering, or regulated industry experience, OR Masters degree with 0-2 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

• Experience in the medical device industry or another highly regulated environment.
• Working knowledge of quality systems, risk management, and design controls.
• Strong written and verbal communication skills, including technical writing.
• Experience supporting released medical device products.
• Hands‑on experience with DFMEA, risk management files, and design change quality reviews.
• Knowledge of medical device lifecycle requirements, including design, manufacturing, distribution, and obsolescence.
• Experience collaborating with cross‑functional teams to resolve quality issues and implement process improvements.
• Familiarity with continuous improvement methodologies and root cause analysis techniques.

Responsibilities

• Develops, modifies, applies, and maintains quality standards and protocols for processing materials into partially finished or finished medical device products.
• Supports and risk assessments associated with design changes, released products, and quality events.
• Reviews, approves, and maintains technical documentation related to engineering and design changes, including risk management files and quality records.
• Performs Design Failure Mode and Effects Analysis (DFMEA) and supports other risk management and technical documentation activities.
• Collaborates with engineering, manufacturing, and cross‑functional teams to ensure appropriate quality standards and controls 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.
• Performs statistical and technical analysis to evaluate nonconforming materials or products and supports root cause investigations.
• Ensures corrective and preventive actions meet acceptable reliability and quality standards and that all documentation complies with applicable requirements.
• Supports investigations and assessments related to potential product quality issues in the released product portfolio.
• Contributes to continuous improvement initiatives, including product and process changes driven by market and business needs.
• May specialize in areas such as design quality, incoming materials, production control, product evaluation and reliability, inventory control, or research and development as they relate 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
• 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