Medtronic · 17 hours ago
Principal Quality Engineer - Post Market Risk
North Haven, CT
Full-time
Onsite
Senior Level, Lead/Staff
$119K/yr - $179K/yr
5+ years expMedtronic is a global healthcare technology leader dedicated to alleviating pain and restoring health. The Principal Quality Engineer will serve as a Subject Matter Expert for Risk Management, managing Risk Management Files and conducting product risk analyses while collaborating with cross-functional teams to ensure product quality and compliance.
Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical Device
Responsibilities
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
Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product
Collaborates with engineering and manufacturing functions to ensure quality standards are in place
Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment
Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements
May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality
Qualification
Required
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)
Company
Medtronic
Medtronic is a healthcare technology company that designs and develops AI-based products and solutions for the medical industry.
10001+ employees
H1B Sponsorship
Medtronic has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (349)
2024 (387)
2023 (291)
2022 (310)
2021 (300)
2020 (261)
Funding
Current Stage
Public CompanyTotal Funding
$18.16BKey Investors
NHS EnglandBlackstone Life SciencesTrade Capital Funding
2025-09-15Post Ipo Debt· $1.76B
2024-05-29Post Ipo Debt· $3.24B
2023-03-23Post Ipo Debt· $2B
Leadership Team
Geoffrey Martha
CEO and Chairman Of The Board Of Directors
Linnea Burman
SVP & President, Neurovascular
Recent News
BioWorld Financial Watch
2026-01-25
Company data provided by crunchbase