Principal Reliability Engineer

Medtronic • North Haven, CT

5d • $132,000 - $198,000

About The Position

Medtronic is seeking a Principal Reliability Engineer for the surgical operating unit’s new product development quality team. The role applies reliability science to medical device product development, with emphasis on developing reliability strategies, planning, and testing to ensure products meet reliability requirements. The position supports product development and may also contribute to design controls and regulatory compliance.

The engineer works with cross-functional teams, including R&D, software reliability, and software development. The role includes reliability planning and testing, test method validation and verification, material and component selection, reliability analysis and modeling, and post-market performance and failure analysis. It also leads and mentors teams in maintaining reliability processes and standards, while ensuring activities are documented and comply with applicable regulations and industry standards.

Requirements

• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Reliability Engineering, or a similar engineering discipline, plus 7 years of relevant experience; or a master’s degree in one of these fields or a similar engineering discipline, plus 5 years of relevant experience.
• For baccalaureate degrees earned outside the United States, a degree satisfying the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Nice To Haves

• ASQ Certified Reliability Engineer (CRE), Design for Reliability and Manufacturing, Six Sigma Green Belt, or equivalent certification.
• AAMI design control certification.
• Experience in reliability engineering.
• In-depth knowledge of regulations and other relevant standards.
• Strong analytical and problem-solving skills, including the ability to conduct thorough root cause analysis.
• Excellent written and verbal communication skills, with the ability to collaborate with cross-functional teams and present complex information to stakeholders.
• Proven leadership and project management skills, including the ability to lead teams and manage multiple projects simultaneously; ability to work independently.
• Industry experience in medical devices, automotive, or aerospace.
• Proficiency in quality management systems, risk management, regulatory compliance, and statistics.
• ReliaSoft software experience.
• LabVIEW experience.
• Sherlock experience.

Responsibilities

• Participate in cross-functional development teams, providing mechanical and/or electrical reliability engineering expertise.
• Write reliability plans and identify reliability activities during product development to meet company, customer, or agency reliability objectives.
• Perform reliability testing, including HALT, ALT, and other discovery tests.
• Support test method validation and verification, including developing and approving test plans, protocols, and final reports.
• Collaborate with R&D to design and implement mechanical and/or electrical reliability tests that identify design weaknesses early in development.
• Support R&D in selecting materials and components to meet defined reliability and performance requirements.
• Perform electrical and/or thermal de-rating analysis as applicable.
• Conduct reliability predictions, modeling, and data analysis to assess product reliability and risk.
• Provide post-market reliability engineering support, including analysis of field performance and failure data.
• Ensure compliance with applicable regulatory and industry standards, including FDA requirements and ISO/IEC standards such as 14971, 13485, 62304, FDA Part 820, and IEC 60601.
• Maintain thorough, accurate, and compliant documentation of reliability engineering activities, including test data, analyses, and reports.
• Lead and mentor teams in developing, implementing, and maintaining reliability processes and standards.
• Partner with software reliability and software development teams as part of mission reliability.
• Collaborate with cross-functional teams to define and implement engineering and statistical processes that ensure product reliability and compliance throughout the product lifecycle.

Benefits

• Competitive salary and flexible benefits package.
• Short-term incentive through the Medtronic Incentive Plan (MIP).
• Health insurance.
• Dental insurance.
• Vision insurance.
• Health Savings Account.
• Healthcare Flexible Spending Account.
• Life insurance.
• Long-term disability leave.
• Dependent daycare spending account.
• Tuition assistance or reimbursement.
• Simple Steps global well-being program.
• Incentive plans.
• 401(k) plan with 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: Principal