Medtronic

Principal Quality Engineer – Post Market Risk

Medtronic

full-time

Posted on:

Location Type: Office

Location: North Haven • Colorado • Connecticut • United States

Visit company website

Explore more

✨ AI Apply
Apply

Salary

💰 $119,200 - $178,800 per year

Job Level

Lead

About the role

  • 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 within the Robotic Surgical Technologies business.
  • 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: 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.

Requirements

  • Requires a Baccalaureate degree and minimum of 7 years of relevant experience OR Master's degree with a minimum of 5 years relevant experience OR PhD with 3 years relevant experience.
Benefits
  • Health, Dental and vision insurance
  • Health Savings Account
  • Healthcare Flexible Spending Account
  • Life insurance
  • Long-term disability leave
  • Dependent daycare spending account
  • Tuition assistance/reimbursement
  • Simple Steps (global well-being program)
  • Incentive plans
  • 401(k) plan plus 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)
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Risk ManagementRisk AnalysisISO14971Benefit Risk AnalysisField Corrective ActionsPost-Market SurveillanceClinical Evaluation ReportHealth Risk AssessmentsPost-Market Issue EvaluationsRisk Management Files
Soft Skills
cross-functional collaborationleadershipcommunicationproblem-solvinganalytical thinking