Quality Engineering Manager, Post-Market Risk – Position Available In South Central Connecticut Planning Region, Connecticut

We anticipate the application window for this opening will close on – 27 Jun 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
• 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 of a Post-Market Risk, Quality Engineering Manager – reporting to Director of Post-Market Risk, Surgical Operating Unit. Responsibilities may include the following and other duties may be assigned.

• Plans, manages and implements aspects of the Surgical Operating Unit’s (SOU) Post-Market Risk Management of medical device products or software systems.
• May develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products in support of Post-Market Risk
• Leads the investigation and evaluation of risk of production and field issues.
• Manages the Post-Market Risk Quality Engineers in support of identifying, controlling, and taking action to mitigate risks associated with existing commercialized product across the assigned product familiess
• Organizes the coordination of activities with team members, outside suppliers and consultants to ensure timely delivery.
• Selects, develops and evaluates personnel to ensure the efficient operation of the team.
• 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
• Advises and coaches team on conducting, and may conduct themself, product Risk Analysis (PHA, RAC) 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
• 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
• Supports and may lead Field Corrective Actions (FCAs). Ensuring smooth collaboration and closure with Medtronic Enterprise team
• Manages Product Hold Orders (PHOs) based upon production and field issues, working with cross-functional teams to develop comprehensive and evidence-based disposition plans
• 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)
• Leads, and may support, team of Risk Quality Engineers evaluating and endorsing Production Post-Production Risk Assessments (PPPRAs) for Change Development Projects (CDPs)
• 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) for assigned product families.
• 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

MINIMUM QUALIFICATIONS

• Requires a Bachelor’s degree in an engineering, math or science discipline
• For degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A)
• Minimum of 5 years of combined experience in quality, engineering or a related function, or an advanced degree with a minimum of 3 years of combined experience in quality, engineering or a related function.

With an additional minimum of 2 years of managerial experience.

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.