Risk Management Quality Engineer I - New Product Development (Surgical)

Medtronic • North Haven, CT

5d • $66,400 - $99,600 • Hybrid

About The Position

Medtronic, a global leader in medical technology, services, and solutions, is seeking a Risk Management Quality Engineer to join our innovative team. This role will be in the surgical operating unit within the new product development quality team. The ideal candidate will have a strong interest in risk management, product development, design controls and regulatory compliance within the medical device industry. This position requires a strong team player who is a self-starter, inquisitive, and a fast learner. This position plays a critical role in the development of medical devices, ensuring patient safety is embedded throughout the product lifecycle.

Requirements

• Bachelors degree in engineering or a related technical field

Nice To Haves

• Experience in medical devices, pharmaceuticals, or combination products
• Familiarity with medical device risk management standards (e.g., ISO 14971 concepts)
• Prior involvement in New Product Development (NPD) environments
• Background in Quality Engineering, Risk Management, R&D, Systems Engineering, or similar roles
• Clinical knowledge or experience supporting clinical risk assessment
• Experience using Minitab or other statistical analysis software
• Certification or experience with Design for Six Sigma / Design for Reliability methodologies
• Strong written, verbal, and digital communication skills
• Proficiency with Microsoft Office tools (Excel, Word, PowerPoint)
• Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent certification, AAMI design control certification is preferred.
• 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.

Responsibilities

• Develop and maintain comprehensive strategies for risk management activities, including: Collaborating cross-functionally to ensure the utmost product quality for patient safety
• Creating and maintaining the risk management file, including the risk management plans and reports, as well as conducting regular risk reviews.
• Leading hazard and risk analysis activities to identify potential risks and implement effective risk control measures.
• Leading Design Failure Modes and Effects Analyses (DFMEAs) in collaboration with project teams to systematically evaluate potential failure modes and their impacts.
• Analyzing and reviewing product complaints to anticipate and prevent future issues.
• Integrating product security measures to protect against potential vulnerabilities into the risk management file.
• Participating in Process FMEA/User FMEA development and integrating the Process FMEA/User FMEA into the risk management file.
• Leading design review and maintaining the risk management file throughout the product lifecycle
• Developing and managing post-market surveillance plans to monitor product performance and safety in the field.
• Leading field issue evaluation (including root cause analysis, risk evaluation, product containment strategy) during initial launch.
• Ensuring traceability between risk management file, requirements and design outputs utilizing a requirements management tool
• Evaluate the safety risk implications of design changes
• Collaborate with cross-functional teams, to define and implement engineering and statistical processes that ensure product quality and compliance throughout the product lifecycle.
• Ensure compliance with relevant regulatory requirements, including FDA, ISO (e.g., 14971, 13485, 62304, FDA Part 820), and other international standards, and participate in regulatory audits and inspections.
• Oversee design validation and design verification activities of user needs and design inputs, including the development of test plans, protocols, test methods and reports.
• Ensure thorough and accurate documentation including test results, risk assessments, and reports.

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: Entry Level