Principal Reliability Engineer

Medtronic • North Haven, CT

4d

About The Position

Medtronic is seeking a Principal Reliability Engineer to join the surgical operating unit’s new product development quality team. The role applies reliability science to medical device product development, including the development of reliability strategies, plans, and testing. It supports products meeting reliability requirements and requires collaboration across engineering and other functions. A solid understanding of design controls and regulatory compliance is preferred.

The engineer contributes mechanical and/or electrical reliability expertise to development teams, supports reliability and test-method activities, and analyzes product reliability and risk throughout the product lifecycle. The role also provides post-market reliability support, maintains compliant documentation, and leads and mentors teams in reliability processes and standards. The position partners with software reliability and software development teams as part of mission reliability.

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.
• Strong analytical and problem-solving skills, including the ability to conduct thorough root cause analysis.
• Excellent written and verbal communication skills and 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.
• Technical proficiency in quality management systems, risk management, regulatory compliance, and statistics.

Nice To Haves

• ASQ Certified Reliability Engineer (CRE), design for reliability and manufacturing, Six Sigma Green Belt or equivalent certification, or AAMI design control certification.
• Experience in reliability engineering.
• In-depth knowledge of regulations and other relevant standards.
• Industry experience in medical devices, automotive, or aerospace.
• Experience with ReliaSoft software.
• Experience with LabVIEW.
• Experience with Sherlock.
• A solid understanding of design controls and regulatory compliance requirements.

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 achieve company, customer, or agency reliability objectives.
• Perform reliability testing, including HALT, ALT, and other discovery tests.
• Support test method validation and verification activities, including developing and approving test plans, protocols, and final reports.
• Collaborate with R&D to design and implement mechanical and/or electrical reliability tests to identify design weaknesses early in development.
• Support R&D in selecting materials and components to achieve defined reliability and performance requirements.
• Conduct 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