Senior Reliability Engineer at Medtronic

Mounds View, Minnesota, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Baccalaureate degree and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience
Thorough understanding and experience in design controls, V&V, and Risk Management - both commercial and development (preferred)
System-thinking and process mapping, ability to effectively identify interfaces, dependencies, and control points (preferred)
Demonstrated ability in stakeholder management and coordinating complex assignments with cross-functional teams (preferred)
Understanding of 21CFR820, ISO13485, and ISO14971 (preferred)
Experience owning or managing a QMS procedure/process (preferred)

Responsibilities

Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs
Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability
Completes risk analysis studies of new design and processes
Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes
Ensures that corrective measures meet acceptable reliability standards
Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives
May develop mathematical models to identify units, batches or processes posing excessive failure risks
As necessary, proposes changes in design or formulation to improve system and/or process reliability
May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data
Primary Product Quality individual contributor responsible for developing, managing, and executing QMS procedure re-writes to harmonize CAS Design Control procedures
Additional product Reliability responsibilities may be included, primarily focused on Affera Capital (HW) equipment DRM, change management, risk management, and risk response

Skills

Reliability Engineering

Design of Experiments

DOE

Statistical Process Control

Risk Analysis

QMS

Design Controls

Product Quality

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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