We anticipate the application window for this opening will close on - 29 Jul 2025

 

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

A Day in the Life of a Principal Quality Engineer, Post-Market Risk

Responsibilities may include the following and other duties may be assigned.
• Serves as Subject Matter Expert for Risk Management across the Post-Market space for their assigned product families
• Accountable for and owns the Risk Management Files for assigned product families
• Maintains Risk Management Files for assigned product families
• Conducts product Risk Analysis (PHA, RAC, SSRCI/System & Use FMEAs) in compliance with ISO14971
• Evaluates product Risk Management Files against field data to ensure accuracy and correctness of predicted risks; validating pre-market Benefit Risk Analysis and updating the Risk Management Files (RMF) as necessitated
• Initiates and manages Product Hold Orders (PHOs) based upon production and field issues, working with cross-functional teams to develop comprehensive and evidence-based disposition plans
• Initiates and drives Post-Market Issue Evaluations (PMIE) and Health Risk Assessments (HRA) to closure based upon production and field issues, taking into consideration inputs from cross-functional teams
• Initiates and serves as owner/lead for Field Corrective Actions (FCAs) based upon HRA decision working alongside Enterprise FCA team
• Supports post-market regulatory body and competent authority engagements, including but not exclusive to:
o Post-Market Surveillance Report (PMSR), Periodic Safety Update Report (PSUR), Clinical Evaluation Report (CER), Summary of Safety and Clinical Performance (SSCP), Clinical Evaluation Plan (CEP), and Requests For Additional Information (RFAI)
• Reviews and endorses Production Post-Production Risk Assessments (PPPRAs) for Change Development Projects (CDPs), as Risk Management SME
• Consults on New Product Development programs during the Product Transfer to ensure Risk Management Files readiness for post-market. Including review of Risk Management Report (RMR) and Post-Market Surveillance Plan (PMSP).
• Supports and collaborates with Post-Market Vigilance team to investigate complaints into potential adverse trends and aids in the early signal detection of field issues

SPECIALIZED SKILLS OR EXPERIENCE
• Risk Management experience in the medical device industry
• Risk Management File lifecycle accountability
• Statistical analysis tools and techniques
• Significant breadth and depth in quality decision making, risk management, quality engineering, reliability engineering, and writing for compliance.
• Knowledge and expertise in FDA 21 CFR 820 & 806, EU MDR (Regulation (EU) 2017/745), ISO 14971, ISO 24971, IEC 60812, and ISO 13485

NICE TO HAVE
• Experience in engaging with Regulatory Agencies and customers / clinicians
• DRM or Six Sigma Certification
• Experience with complex capital equipment or disposable medical devices or medical device software
• Reliability Engineering test experience
• Typically has deep domain expertise and applies extensive engineering and industry expertise
• Knowledge of IEC 62366-1, IEC 60601-1, IEC 62304, IEC 82304, BS/AAMI 34971

TRAVEL REQUIREMENTS
• Occasional visits to product manufacturing and design centers, as well as potential visits to Regulatory Bodies as needed. <10%

Responsibilities may include the following and other duties may be assigned.

• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibilit