Sr Design Quality Manager at Medtronic

Lafayette, Colorado, 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

Bachelor’s Degree with 7+ years of work experience in Quality, with 5+ years of managerial experience OR Advanced Degree with 5+ years of work experience in Quality with 5+ years of managerial experience
Experience leading complex projects/programs
Experience managing a global team of Quality Professionals
Experience with Design Control, Change Development processes, CAPA
Effective planning and organization skills including the proven ability to work against multiple objectives simultaneously
Ability to establish and maintain a trusted role with the various stakeholders in coordinating multiple functions across the organization
Strong working knowledge of Quality System Regulations such as (QSR 21 CFR 820), and ISO 13485:2016
Experience creating and maintaining Risk Management Files to the latest ISO 14971 standards

Responsibilities

Apply your technical expertise to Put Patients First every day
Guide cross-functional teams through the Change Development Process (CDP) with a strong focus on positive design control outcomes and adherence to our QMS
Apply Design for Reliability and Design for Manufacturability principles to reduce risk, improve First Time Quality (FTQ), and enable efficient design transfer
Serve as a subject matter expert in CAPA and Post-Market Surveillance (PMS), ensuring field performance insights are incorporated into product changes
Apply systems engineering principles to coordinate complex, multi-disciplinary product change efforts from concept through commercialization
Leverage engineering knowledge to ensure designs meet functional, safety, and efficacy requirements in compliance with medical device standards
Maintain deep familiarity with FDA 21 CFR Part 820, ISO 13485, and other design-controlled regulations, providing expert guidance on compliance throughout the Change Development Process and product lifecycle
Partner closely with R&D and Quality colleagues to embed best practices in technical rigor, simplify execution, and bring forward individual perspectives that strengthen decision-making and solution design

Skills

Design Controls

Risk Management

Change Control

Design for Reliability

Design for Manufacturability

CAPA

Post-Market Surveillance

Systems Engineering

Quality Management System

Released Product Engineering

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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