Quality Engineer I

Medtronic • North Haven, CT

1d • 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 Medtronic, a global leader in medical technology, services, and solutions, is seeking a highly skilled and experienced Quality Engineer I 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 background 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. Responsibilities may include the following and other duties may be assigned.

Requirements

• Bachelor’s degree require and 0 years of relevant experience.
• Proficient in quality management systems, risk management, regulatory compliance, and statistics.
• Basic knowledge of human anatomy/physiology and surgical procedures.
• 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

• Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent certification, AAMI design control certification is preferred.
• Regulated engineering field
• Medical device industry.

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.
• Perform additional duties as assigned.

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