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 related field
Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience
Electrical Engineering experience preferred
PCBA manufacturing/testing/designing experience preferred
Supplier quality engineering experience preferred
Experience with PCBA suppliers and validation of PCBA test and manufacturing processes strongly preferred (Nice to Have)
Medical device manufacturing industry experience, preferably ISO 13485 (Nice to Have)
Lead auditor experience (Nice to Have)
Hands-on experience with SAP, Trackwise, Agile change management (Nice to Have)
Ability to manage tasks

Responsibilities

Supplier selection and qualification while ensuring suppliers deliver quality parts, materials, and services
Monitor parts from acquisition through the manufacturing cycle, promptly identifying and resolving supplier-related problems
Develop and prioritize an auditing schedule to ensure suppliers meet GMP and quality standards through regular audits
Evaluate suppliers' internal functions to assess overall performance and provide feedback
Manage Non-Conformance Material Reports (NCMRs) on materials-related quality issues and trends (Incoming, Production, Sterilization)
Handle suppliers' change requests, including communication, project management via MAP Agile workflow, and regular reporting
Manage the Approved Supplier List, including administrative work in MAP Agile
Qualify materials through the Production Part Approval Process (PPAP), including process validation, test method validation, technical writing, and project management
Improve suppliers' performance and reduce escapes to manufacturing
Execute Process validation IQ/OQ/PQ and Master Validation Planning in new product development
Knowledgeable in Statistical analysis (MSA, Capability, SPC)
Support DFMEA and PFMEA activities
Identification of critical to quality parameters and process controls in collaboration with designers and cross-functional team
Design Transfer; translating design specifications into production specifications
Use project management skills to ensure that supplier processes are developing at the appropriate cadence to support engineering builds and Design Verification and Validation
Provide mentorship and coaching
Occasional travel to visit suppliers within the United States and internationally

Skills

Supplier Quality Engineering

PCBA Manufacturing

PCBA Testing

PCBA Design

Supplier Auditing

GMP

Supplier Qualification

Electrical Engineering

New Product Development

Design Transfer

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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