Senior Post-Market Risk Quality Engineer
Medtronic
Senior Post-Market Risk Quality Engineer
Medtronic
full-time
Posted on:
Location Type: Office
Location: North Haven • Connecticut, Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $96,800 - $145,200 per year
Job Level
Senior
About the role
- responsibility for providing risk management expertise and best practices for released products and post-market activities within the Advanced Surgical Technologies organization.
- This includes evaluating product issues to ensure patient, user and security risk are assessed
- acting as the Quality Engineer Risk Management file owner for the CSI capital hardware and disposable products.
- 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
- 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.
- 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 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 6 years of combined experience in quality, engineering or a related function, or an advanced degree with a minimum of 4 years of combined experience in quality, engineering or a related function
- 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
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
Risk ManagementRisk AnalysisStatistical analysisQuality engineeringReliability engineeringBenefit Risk AnalysisField Corrective ActionsPost-Market Issue EvaluationsHealth Risk AssessmentsProduct Hold Orders
Soft skills
Cross-functional collaborationDecision makingCommunicationProblem solvingLeadership
Certifications
Bachelor’s degree in engineeringBachelor’s degree in mathBachelor’s degree in science