Quality Engineer II at Medtronic

North Haven, Connecticut, United States

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Bachelor’s degree AND minimum of 2 years of relevant experience OR Advanced degree with 0 years of experience
Familiarity with FDA regulations (21 CFR Part 820), ISO 13485, and quality systems (preferred)
Strong analytical, problem-solving, and effective communication skills (preferred)
Strong interpersonal and influencing skills (preferred)
2+ years of relevant quality, manufacturing, or product development experience in a regulated industry (medical device preferred) (preferred)
Experience with CAPA, risk management tools, and statistical analysis (preferred)
Lean, Six Sigma, or quality certifications (e.g., ASQ CQE) (preferred)
Hands-on knowledge of root cause investigation and validation protocols (preferred)
Experience working in an inclusive, cross-functional team setting (preferred)

Responsibilities

Support product and process quality for Class II/III medical devices in a regulated manufacturing environment
Lead and support nonconformance investigations, CAPA (Corrective and Preventive Actions), and root cause analysis
Perform risk assessments and support risk management documentation (FMEA, fault tree analysis)
Provide quality engineering support for design changes, process improvements, and product launches
Review and approve validations, protocols, and test methods (IQ/OQ/PQ, MSA, etc.)
Analyze quality trends, monitor metrics, and recommend data-driven actions
Collaborate across functions (R&D, Manufacturing, Regulatory, and Supplier Quality) to ensure compliance and product integrity
Support audits and inspections (internal, supplier, and regulatory bodies)
Contribute to fostering a culture of inclusion, safety, and continuous learning

Skills

CAPA

Root Cause Analysis

FMEA

IQ/OQ/PQ

MSA

FDA 21 CFR Part 820

ISO 13485

Nonconformance Investigations

Risk Management

Process Validation

Quality Metrics

Audits

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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