Prin Quality Engineer 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, HealthcareIndustries

Requirements

Baccalaureate degree and minimum of 7 years of relevant experience OR Master's degree with a minimum of 5 years relevant experience OR PhD with 3 years relevant experience
Recognized expert capable of managing large projects or processes with considerable latitude in determining deliverables and limited oversight
Ability to contribute to defining direction for new products, processes, standards, or operational plans based on business strategy
Expertise in solving difficult, moderately complex, and undefined problems through detailed information gathering, analysis, and investigation
Strong communication skills to represent the organization as primary contact for projects, negotiate with internal/external stakeholders, and influence decision-making
Leadership skills to provide guidance, coaching, training, delegate work, review work products, and act as team leader

Responsibilities

Lead and mentor teams in the development, implementation, and maintenance of quality assurance processes and standards
Collaborate with cross-functional teams, including R&D, manufacturing, NPD, and regulatory affairs, to define and implement systems engineering processes ensuring product quality and compliance throughout the product lifecycle
Conduct risk assessments and manage risk mitigation activities in accordance with ISO 14971 and other applicable standards
Ensure compliance with all relevant regulatory requirements, including FDA, ISO, and other international standards, and participate in regulatory audits and inspections
Oversee validation and verification activities, including the development of test plans, protocols, and reports to ensure products meet specified requirements
Ensure thorough and accurate documentation of quality assurance activities, including test results, risk assessments, and compliance reports
Formulate, deliver, and/or manage projects assigned, working with stakeholders to achieve desired results, while adhering to policies using specialized knowledge and skills
Advance existing technology or introduce new technology and therapies, primarily delivering R&D, systems, or initiatives from design to implementation

Skills

Key technologies and capabilities for this role

Quality AssuranceISO 14971FDA ComplianceISO StandardsRisk AssessmentValidationVerificationTest PlansRegulatory AuditsSystems EngineeringR&DProduct LifecycleMentoring

Questions & Answers

Common questions about this position

What is the employment type for this Principal Quality Engineer position?

The position is full-time.

Is this Principal Quality Engineer role remote or office-based?

This information is not specified in the job description.

What key skills are required for the Principal Quality Engineer role?

Key skills include leading quality assurance processes, conducting risk assessments per ISO 14971, ensuring regulatory compliance with FDA and ISO standards, and overseeing validation and verification activities.

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

Medtronic emphasizes a culture of exploration, innovation, leading with purpose, and championing healthcare access and equity in a connected, compassionate world.

What makes a strong candidate for the Principal Quality Engineer position?

Strong candidates are recognized experts with autonomy to manage large projects, contribute to defining new products or processes, solve moderately complex problems independently, and mentor lower-level professionals.

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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