Quality Engineering Program Manager - SH&A at Medtronic

Galway, County Galway, Ireland

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Bachelor's degree and a minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience
Working knowledge of FDA regulations and ISO standards applicable to implantable medical devices
5 years of experience working in the regulated medical device industry
Root cause analysis and leading technical investigations with cross functional groups
Lead projects to solve technical problems or process improvement programs and ability to manage stakeholders and work cross functionally
Work on health risk assessments/product holds and recalls
Experience working in post market quality/complaint handling teams

Responsibilities

Leading product escalations across cross functional groups
Monitoring product performance, complaint investigations, and evaluating quality issues impacting released product
Design Assurance activities supporting changes to commercial products
Mentor team members through technical problem solving including CAPA investigations and triaging issues
Provide technical knowledge and input into risk assessments when quality issues are being evaluated
Provide front room support during inspections from regulatory agencies (e.g. FDA, FDB, Notified Body)
Demonstrate the ability to communicate, influence, and negotiate with internal cross-functional employees, internal leaders at all levels and external customers in the pursuit of product quality improvements and post-market risk management
Create strategic plans for driving efficiencies, improving competencies, and developing people to continuously improve function
Provide oversight and expertise in risk management activities
Ability to effectively communicate and provide updates on high visibility patient impacting issues to senior leadership

Skills

Key technologies and capabilities for this role

Quality EngineeringProduct EscalationsComplaint InvestigationsCAPADesign AssuranceRisk ManagementRegulatory InspectionsFDACross-Functional LeadershipTechnical Problem Solving

Questions & Answers

Common questions about this position

What compensation does Medtronic offer for this Quality Engineering Program Manager role?

Medtronic offers a competitive salary and flexible Benefits Package.

Is this Quality Engineering Program Manager position remote or office-based?

This information is not specified in the job description.

What are the key skills and experience required for this role?

Candidates need a Bachelor's degree with 5 years of relevant experience or an advanced degree with 3 years, working knowledge of FDA regulations and ISO standards for implantable devices, 5 years in regulated medical device industry, root cause analysis, leading investigations cross-functionally, and experience with health risk assessments, recalls, and post-market quality.

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

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

What makes a strong candidate for the Quality Engineering Program Manager position?

Strong candidates have experience leading cross-functional technical investigations, root cause analysis, risk management, regulatory inspections, and post-market quality handling in the medical device industry, along with the ability to mentor teams and communicate with senior leadership.

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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