Principal Reliability Engineer

Medtronic, a global leader in medical technology, services, and solutions, is seeking a highly skilled and experienced Principal Reliability 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 bring a strong background in reliability science, with demonstrated experience developing reliability strategies for new products, including reliability planning and testing. This role also supports medical device product development, and a solid understanding of design controls and regulatory compliance requirements is preferred. This position requires a strong team player who is a self-starter, inquisitive, and a fast learner. This role will be pivotal in ensuring the development of medical devices that meet reliability requirements.

Responsibilities may include the following, as well as other duties that may be assigned.

• 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 that includes HALT, ALT and other discovery tests
• Support test method validation and verification activities, including the development and approval of 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
• 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 (e.g., 14971, 13485, 62304, FDA Part 820, IEC 60601).
• Maintain thorough, accurate, and compliant documentation of all reliability engineering activities, including test data, analyses, and reports.
• Lead and mentor teams in the development, implementation, and maintenance of the reliability processes and standards.
• Partnering 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.

• Bachelor's Degree in Mechanical/Electrical Engineering or Reliability Engineering or similar engineering degree with 7 years of relevant experience OR a Master's degree in Mechanical/Electrical or Reliability Engineering or similar engineering degree with 5 years of relevant experience.

• 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 field.
• Regulatory Knowledge: In-depth knowledge of regulations and other relevant standards.
• Problem-Solving: Strong analytical and problem-solving skills with the ability to conduct thorough root cause analysis.
• Communication: Excellent written and verbal communication skills, with the ability to effectively collaborate with cross-functional teams and present complex information to stakeholders.
• Leadership: Proven leadership and project management skills with the ability to lead teams and manage multiple projects simultaneously. Able to work independently
• Industry Experience: Medical device/Automotive/Aerospace industry.
• Technical Skills: Proficient in quality management systems, risk management, regulatory compliance, and statistics.
• ReliaSoft software experience
• LabVIEW experience
• Sherlock 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.