Sr Quality Engineer at Medtronic

North Haven, Connecticut, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Bachelor’s degree in Engineering, or a related technical field and 4 years relevant experience or a Master Degree and 2 years of relevant experience
Proficient in hardware engineering methodologies, quality assurance practices, design verification, DFMECA, and regulatory compliance (nice to have)
Experience in Quality Assurance, Engineering (nice to have)
Medical device industry experience (nice to have)
Certifications: Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent certification (preferred, nice to have)

Responsibilities

Lead and mentor teams in the development, implementation, and maintenance of quality assurance processes and standards
Define and manage sub-systems requirements to ensure clarity, completeness, and testability. Define requirements and assess risk through the use of DFMEA/DFMECA
Support engineering teams in the development of Critical to Function (CTF) matrixes for identification of critical functions and connecting these functions to specific design requirements
Responsible for planning, executing, and documenting design verification activities to ensure product designs meet specified requirements and regulatory standards
Support design, technical, and print reviews as part of the design verification process
Ensure thorough and accurate documentation of quality assurance activities, including test results, risk assessments, and compliance reports
Oversee validation and verification activities, including the development of test plans, protocols, and reports to ensure that products meet specified requirements
Ensure compliance with all relevant regulatory requirements, including FDA, ISO, and other international standards, and participate in regulatory audits and inspections
Evaluate product reliability through Reliability assessments and Test Systems Development
Collaborate with cross-functional teams, including R&D, manufacturing, NPD and regulatory affairs, to define and implement hardware engineering processes that ensure product quality and compliance throughout the product lifecycle

Skills

Hardware Engineering

Reliability Testing

Quality Assurance

Regulatory Compliance

DFMEA

DFMECA

Design Verification

CTF Matrix

Test Plans

Validation Protocols

Risk Assessment

Medical Device Design

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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