Senior Hardware Design Quality Engineer – Medical Devices

ATR International; Los Angeles (CA); On-site; USD 61,992 - 86,788; Part time

Job summary

A leading technical staffing firm in Los Angeles is seeking a Sr. Hardware Design Assurance Engineer to bolster quality engineering for medical devices. This contract position entails providing design verification support while adhering to regulatory standards. The ideal candidate will possess a Bachelor's degree in Electrical Engineering and several years of relevant experience in medical products. A commitment to process improvement is essential, alongside effective communication skills. The role prioritizes quality assurance and engineering expertise.

Qualifications

• 3-6+ years of design quality experience preferably with medical device products.
• Detailed knowledge of FDA 21CFR 820, GMP, MDD and EU-MDR.
• Experience with planning and executing design verification testing.

Responsibilities

• Provide quality engineering support throughout the product development lifecycle.
• Serve as a Subject Matter Expert and own Risk Management.
• Support design verification, validation, and reliability testing.

Skills

Quality engineering

Risk Management

Design verification

Problem-solving methodologies

Process validation

Education

Bachelor’s degree in electrical engineering

Tools

FDA 21CFR 820

ISO 13485

IEC 60601‑1

GMP

Job description

A leading technical staffing firm in Los Angeles is seeking a Sr. Hardware Design Assurance Engineer to bolster quality engineering for medical devices. This contract position entails providing design verification support while adhering to regulatory standards. The ideal candidate will possess a Bachelor's degree in Electrical Engineering and several years of relevant experience in medical products. A commitment to process improvement is essential, alongside effective communication skills. The role prioritizes quality assurance and engineering expertise.