Principal Reliability Engineer - CS at Medtronic

Mounds View, Minnesota, 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, Healthcare, Cardiac SurgeryIndustries

Requirements

Support all aspects of Quality related to the commercial portfolio, including Health Risk Assessments, Post Market Surveillance, and Risk Management
Own the risk management file and all associated activities
Lead root cause investigations and CAPAs
Perform Health Risk Assessments
Support Field Corrective Actions (FCAs)
Perform Post-Market Surveillance
Collaborate with Quality, RPE, Regulatory, and Manufacturing colleagues to address product issues, compliance concerns, supplier and manufacturing non-conformities cost-effectively
Understand design and risk implications to changes
Collaborate cross-functionally
Generate and review DFMEAs, test method validations, and test reports in compliance with design control and risk management procedures in the medical device industry
Work in a fast-paced, multi-tasking, team environment
Less than 10% travel
On-site work 4 days per week in Mounds View, MN

Responsibilities

Support risk assessments and hazard analyses based on post-market data
Lead Health Risk Assessments to determine potential risk and recommend need for Field Corrective Action (FCA)
Monitor product performance in the field
Collect and analyze reliability data
Identify trends and potential issues
Lead investigations into product failures and complaints, utilizing root cause analysis techniques to determine underlying causes
Support complaint trending and investigations of complaint trend excursions or quality signals from the field
Prepare and present reliability reports, metrics, and recommendations to regulatory authorities as required
Collaborate with design, manufacturing, and quality teams to implement design improvements (inferred from continuous improvement context)

Skills

Reliability Engineering

Risk Management

DFMEA

Root Cause Analysis

CAPA

Health Risk Assessments

Post Market Surveillance

Field Corrective Actions

Test Method Validation

FMEA

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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