Principal Quality Engineer - Post Market Risk at Medtronic

North Haven, Connecticut, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Technical specialist in quality engineering, with expertise in risk management, particularly post-market surveillance and ISO 14971 compliance
Experience conducting product risk analyses (PHA, RAC, SSRCI/System & Use FMEAs)
Knowledge of post-market processes including PMSR, PSUR, CER, SSCP, CEP, RFAI, PHOs, PMIE, HRA, and FCAs
Ability to perform statistical analysis, design inspection/testing mechanisms, and ensure compliance with quality standards
Skills in collaborating with cross-functional teams (engineering, manufacturing, vigilance, regulatory)
Capability to mentor colleagues or direct lower-level professionals
Familiarity with production post-production risk assessments (PPPRAs), change development projects (CDPs), and new product development transfers

Responsibilities

Serves as Subject Matter Expert for Risk Management across the Post-Market space for 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, validating pre-market Benefit Risk Analysis and updating RMF as needed
Initiates and manages Product Hold Orders (PHOs) based on production and field issues, developing disposition plans with cross-functional teams
Initiates and drives Post-Market Issue Evaluations (PMIE) and Health Risk Assessments (HRA) to closure
Initiates and serves as owner/lead for Field Corrective Actions (FCAs) based on HRA decisions
Supports post-market regulatory engagements (PMSR, PSUR, CER, SSCP, CEP, RFAI)
Reviews and endorses Production Post-Production Risk Assessments (PPPRAs) for Change Development Projects (CDPs)
Consults on New Product Development programs during Product Transfer, reviewing RMR and PMSP
Supports Post-Market Vigilance team in investigating complaints, detecting adverse trends, and early signal detection
Develops, modifies, applies, and maintains quality standards and protocols for processing materials into products
Collaborates with engineering and manufacturing to ensure quality standards
Devises and implements methods for inspecting, testing, and evaluating products and equipment
Designs or specifies inspection and testing mechanisms, conducts quality assurance tests, and performs statistical analysis
Ensures corrective measures meet reliability standards and documentation complies with requirements

Skills

Key technologies and capabilities for this role

Risk ManagementISO 14971PHAFMEAPost-Market SurveillanceProduct Hold OrdersHealth Risk AssessmentsField Corrective ActionsPMSRPSURCERSSCP

Questions & Answers

Common questions about this position

What is the employment type for this Principal Quality Engineer role?

This is a full-time position.

Is this Principal Quality Engineer role remote or office-based?

This information is not specified in the job description.

What key skills are required for the Principal Quality Engineer - Post Market Risk position?

The role requires expertise in Risk Management per ISO14971, conducting product risk analyses like PHA, RAC, SSRCI/System & Use FMEAs, and experience with post-market surveillance activities including PMIE, HRA, and FCAs.

What is the company culture like at Medtronic for this role?

Medtronic emphasizes a lifelong career of exploration and innovation, leading with purpose to champion healthcare access and equity, while breaking down barriers to innovation in a connected, compassionate world.

What makes a strong candidate for the Principal Quality Engineer role?

Strong candidates will have deep expertise as a Subject Matter Expert in post-market Risk Management for medical devices, ownership experience with Risk Management Files, and the ability to lead cross-functional teams on issues like PHOs, PMIEs, HRAs, and FCAs.

Medtronic

Develops and manufactures medical devices and therapies

About Medtronic

Medtronic provides medical technology, services, and solutions to improve patient care. The company develops a variety of medical devices, including pacemakers, insulin pumps, surgical tools, and neurostimulation devices, which help diagnose, prevent, and treat chronic diseases. These products are used by hospitals, clinics, and healthcare professionals around the world. Medtronic stands out from competitors by investing significantly in research and development to create new products and offering additional services like training and patient management programs. The goal of Medtronic is to enhance patient outcomes and lower healthcare costs through its comprehensive range of medical solutions.

Fridley, MinnesotaHeadquarters

1949Year Founded

$3.2MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Employee Assistance Program

Wellness Program

Risks

Emerging competitors like Fire1 threaten Medtronic's heart failure management market share.

Spine biologics market growth may attract new entrants, increasing competition for Medtronic.

Recent IPOs in medtech indicate rising competition, challenging Medtronic's market position.

Differentiation

Medtronic's diverse product range spans cardiovascular, diabetes, neurological, and surgical technologies.

The company invests heavily in R&D to drive innovation in medical devices.

Medtronic offers comprehensive services, including training and technical support, enhancing product value.

Upsides

Exclusive deal with Kuros enhances Medtronic's orthopedic portfolio and market share.

Growing spine biologics market offers expansion opportunities in spinal fusion and regenerative medicine.

Balloon catheters market growth aligns with Medtronic's recent product launches, boosting cardiovascular presence.

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