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
- evaluates 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, 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
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
- Experience in engaging with Regulatory Agencies and customers / clinicians (NICE TO HAVE)
- DRM or Six Sigma Certification (NICE TO HAVE)
- Experience with complex capital equipment or disposable medical devices or medical device software (NICE TO HAVE)
- Reliability Engineering test experience (NICE TO HAVE)
- Typically has deep domain expertise and applies extensive engineering and industry expertise (NICE TO HAVE)
- Knowledge of IEC 62366-1, IEC 60601-1, IEC 62304, IEC 82304, BS/AAMI 34971 (NICE TO HAVE)
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 engineeringISO 14971ISO 13485FDA 21 CFR 820ISO 24971IEC 60812
Soft skills
Cross-functional collaborationDecision makingCommunicationProblem solvingLeadership
Certifications
DRM CertificationSix Sigma Certification