Medtronic
Sr Post-Market Risk Quality Engineer
– Medtronic
Overview Medtronic is a global leader in medical technology dedicated to improving and extending life. The Sr Post-Market Risk Quality Engineer role focuses on applying risk management expertise to released devices, ensuring patient, user, and system safety, and leading post-market investigations and corrective actions.
Responsibilities
Serve as Subject Matter Expert for Post‑Market Risk Management across assigned product families.
Own and maintain Risk Management Files (RMF) for assigned product families, ensuring up‑to‑date and accurate risk data.
Conduct product risk analyses (PHA, RAC, SSRCI/System & Use FMEAs) in compliance with ISO14971.
Evaluate RMFs against field data to verify accuracy of predicted risks; update RMFs as needed.
Initiate and manage Product Hold Orders (PHOs) and Post‑Market Issue Evaluations (PMIEs) with cross‑functional teams.
Lead Field Corrective Actions (FCAs) based on Health Risk Assessments (HRAs) and coordinate with the Enterprise FCA team.
Support regulatory engagements (PMSR, PSUR, CER, SSCP, CEP, RFAI) and review Production Post‑Production Risk Assessments (PPPRAs) for Change Development Projects.
Consult on New Product Development during Product Transfer to ensure RMF readiness for post‑market.
Collaborate with Post‑Market Vigilance to investigate complaints and detect early field‑issue signals.
Qualifications
Bachelor’s degree in an engineering, math, or science discipline.
Minimum of 6 years of combined experience in quality, engineering or a related function (or an advanced degree with at least 4 years of related experience).
Risk Management experience in the medical device industry and RMF lifecycle accountability.
Statistical analysis tools and techniques; strong quality decision‑making and risk‑management expertise.
Knowledge of FDA 21 CFR 820 & 806, EU MDR, ISO 14971, ISO 24971, IEC 60812, ISO 13485.
Preferred: Experience engaging with regulatory agencies, DRM or Six Sigma certification, complex capital equipment or disposable device or medical device software background, reliability engineering test experience, and deep domain expertise.
Travel Requirements Occasional visits to product manufacturing and design centers, and potential visits to regulatory bodies as needed.
Physical Job Requirements Regular office duties: independent mobility, interaction with a computer, communication with peers and co‑workers. Reasonable accommodations available for individuals with disabilities.
Benefits & Compensation Salary Range (U.S. excl. PR) : $96,800 – $145,200 (USD). Eligible for a short‑term incentive (Medtronic Incentive Plan – MIP). Compensation varies by experience, certification, education, and market conditions.
Health, Dental, Vision, Health Savings Account, Flexible Spending Account, Life Insurance, Long‑term Disability, Dependent Daycare, Tuition Reimbursement, and Simple Steps global well-being program available to employees working 20+ hours per week.
Retirement: 401(k) plan with employer match and match, non‑qualified retirement plan supplement, and short‑term disability. Eligible employees receive incentive plans, employee stock purchase plan, employee assistance program, and capital accumulation plan (subject to IRS earning minimums). Temporary employees receive paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan.
EEO Statement (Medtronic): Medtronic provides equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state, or local law. Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Quality Assurance
Industries Medical Equipment Manufacturing, Hospitals and Health Care, and Pharmaceutical Manufacturing
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– Medtronic
Overview Medtronic is a global leader in medical technology dedicated to improving and extending life. The Sr Post-Market Risk Quality Engineer role focuses on applying risk management expertise to released devices, ensuring patient, user, and system safety, and leading post-market investigations and corrective actions.
Responsibilities
Serve as Subject Matter Expert for Post‑Market Risk Management across assigned product families.
Own and maintain Risk Management Files (RMF) for assigned product families, ensuring up‑to‑date and accurate risk data.
Conduct product risk analyses (PHA, RAC, SSRCI/System & Use FMEAs) in compliance with ISO14971.
Evaluate RMFs against field data to verify accuracy of predicted risks; update RMFs as needed.
Initiate and manage Product Hold Orders (PHOs) and Post‑Market Issue Evaluations (PMIEs) with cross‑functional teams.
Lead Field Corrective Actions (FCAs) based on Health Risk Assessments (HRAs) and coordinate with the Enterprise FCA team.
Support regulatory engagements (PMSR, PSUR, CER, SSCP, CEP, RFAI) and review Production Post‑Production Risk Assessments (PPPRAs) for Change Development Projects.
Consult on New Product Development during Product Transfer to ensure RMF readiness for post‑market.
Collaborate with Post‑Market Vigilance to investigate complaints and detect early field‑issue signals.
Qualifications
Bachelor’s degree in an engineering, math, or science discipline.
Minimum of 6 years of combined experience in quality, engineering or a related function (or an advanced degree with at least 4 years of related experience).
Risk Management experience in the medical device industry and RMF lifecycle accountability.
Statistical analysis tools and techniques; strong quality decision‑making and risk‑management expertise.
Knowledge of FDA 21 CFR 820 & 806, EU MDR, ISO 14971, ISO 24971, IEC 60812, ISO 13485.
Preferred: Experience engaging with regulatory agencies, DRM or Six Sigma certification, complex capital equipment or disposable device or medical device software background, reliability engineering test experience, and deep domain expertise.
Travel Requirements Occasional visits to product manufacturing and design centers, and potential visits to regulatory bodies as needed.
Physical Job Requirements Regular office duties: independent mobility, interaction with a computer, communication with peers and co‑workers. Reasonable accommodations available for individuals with disabilities.
Benefits & Compensation Salary Range (U.S. excl. PR) : $96,800 – $145,200 (USD). Eligible for a short‑term incentive (Medtronic Incentive Plan – MIP). Compensation varies by experience, certification, education, and market conditions.
Health, Dental, Vision, Health Savings Account, Flexible Spending Account, Life Insurance, Long‑term Disability, Dependent Daycare, Tuition Reimbursement, and Simple Steps global well-being program available to employees working 20+ hours per week.
Retirement: 401(k) plan with employer match and match, non‑qualified retirement plan supplement, and short‑term disability. Eligible employees receive incentive plans, employee stock purchase plan, employee assistance program, and capital accumulation plan (subject to IRS earning minimums). Temporary employees receive paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan.
EEO Statement (Medtronic): Medtronic provides equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state, or local law. Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Quality Assurance
Industries Medical Equipment Manufacturing, Hospitals and Health Care, and Pharmaceutical Manufacturing
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