Sr. Product Test Engineer - Product Verification & Reliability Engineering

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.      

Bachelor’s degree in engineering or science with 4+ years of work experience in medical device development and/or design quality

OR

Master’s Degree in Engineering or Science with 2+ years of work experience in medical device development and/or design quality.

Nice to Have 

• Experience working in a regulated industry (e.g., FDA-regulated)
• Master’s Degree in Engineering, Quality, Regulatory, or related.
• Working knowledge of electromechanical medical devices with embedded firmware and systems with mobile and cloud applications
• Experienced with statistical analysis of data (e.g., MiniTab, Weibull ++, etc.)
• Experience with DFMEA, Accelerated Life Testing, Risk Analysis, Reliability Growth, and/or Demonstration Testing
• Ability to track multiple tasks and projects and create custom dashboards to engage the team, identify gaps and opportunities, and report progress.
• Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, IEC 62304, IEC 60601-1, MDD & EU MDR.
• Experience in Design-Reliability-Manufacturing (DRM) or equivalent corporate design and/or manufacturing process improvement initiative
• Experience with leading large, complex initiatives of strategic importance to the business unit, involving large cross-functional teams
• Project experience in hardware testing practices, methodologies, and techniques, particularly in testing medical devices is a plus
• Ability to author technical reports, business correspondence and standard operating procedures.
• Ability to apply knowledge and work with development and supply vendors to ensure compliance to Medtronic requirements
• FDA regulatory experience- e.g., presenting during FDA audits, responding to regulatory inquiries, communicating directly with FDA statisticians
• Strong verbal and written English communication skills with an ability to effectively communicate at multiple hierarchal levels in the organization.
• Ability to multi-tasks, prioritize, meets/exceed deadlines and hold themselves, and others accountable.
• Self-Starter with a sharp focus on quality and customer experience

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here.

This position is eligible for a short-term incentive plan.  Learn more about Medtronic Incentive Plan (MIP) on page 6 here.