Senior Principal Reliability Engineer - Cardiac Ablation Solutions at Medtronic

Galway, County Galway, Ireland

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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

Minimum Level 8 Degree in Engineering or other relevant discipline and minimum 10 years of relevant experience (or advanced Degree with a minimum of 8 years of relevant experience)
Advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience
Experience in a highly regulated industry, preferably medical devices
Experience with solving complex issues by interacting with cross functional groups
Proven ability to operate in a matrix organization and navigate complex business systems, regulations, standards, and performance requirements
Knowledge of reliability tools and practices that effectively support requirements, design, integration and verification, and validation
Demonstrated critical thinking skills with focus on improved system performance outcomes and positive business impact
Excellent communication and ability to influence
May have practical knowledge of project management
Understand risk management concepts used throughout the quality system to successfully meet FDA, ANSI/AAMI/ISO 14971:2019, and ANSI/AAMI/ISO 13485:2016 requirements

Responsibilities

Works closely with Research & Development in the development of Test methods to ensure that they are ready for the Test Method Validation (TMV) process
Ensures all TMV’s are validated to meet the required TMV procedure and standards
Takes direction from the quality core team member in delivering day to day project deliverables as an extended QCTM
Collaborates with engineering and manufacturing functions to ensure quality standards are in place
Perform systematic reliability analysis against features, requirements, architecture, interfaces, and designs, through the appropriate application of reliability engineering techniques (e.g. fault tree analysis, failure trending and analysis, reliability forecasting, etc.) to understand product and process robustness
Lead strategies for test method validations, design verification and shelf-life protocols / reports

Skills

Reliability Engineering

Test Method Development

Test Method Validation

TMV

Quality Assurance

Statistical Analysis

Medical Device Testing

R&D Collaboration

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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