Sr. Hardware Design Assurance Engineer

ATR International is a widely renowned technical staffing and consulting leader. Our firm has grown to serve a range of companies—from startups to Fortune 500 organizations. And we support a plethora of industries, from IT, engineering, telecommunications, and finance to healthcare, insurance, and retail. By bringing passion for excellence, trust, and inclusion to every interaction, we build deep connections with our clients, contractors, and local markets to drive long‑term mutual success.

Our passion for inclusion is at the heart of our success. Our woman‑led, minority‑owned firm welcomes fresh perspectives, and our efforts have earned us WBENC Certification - the most prestigious national recognition for women‑owned businesses in the U.S. Today, ATR remains one of the most diverse firms in the staffing industry.

Base pay range: $45.00/hr - $63.00/hr

As a Sr. Hardware Design Assurance Engineer, you will leverage your deep expertise in hardware quality engineering to support the development of medical devices from a pre‑market perspective.

• Provide quality engineering support throughout the product development lifecycle by applying ISO 13485, ISO 14971, and FDA design control principles to ensure compliance.
• Serve as a Subject Matter Expert and own Risk Management (Hazards Analysis and FMEAs) across the assigned product / product families (mainly complex electro‑mechanical devices).
• Support design verification, validation, and reliability testing.
• Identify and implement effective process control systems to support the development, qualification, and ongoing manufacturing of products to meet or exceed internal and external requirements, supporting design transfer activities.
• Apply sound, systematic problem‑solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Support audits, CAPA investigations, and continuous improvement initiatives.

• Bachelor’s degree in electrical engineering or other equivalent fields of study is required.
• 3-6+ years of design quality experience preferably with medical device products.
• Detailed knowledge of FDA 21
  
  CFR 820, GMP, MDD and EU‑MDR, and ISO 13485 and ISO 14971.
• Engineering and technical experience and demonstrated use of Quality tools/methodologies.
• Experience with planning and executing design verification testing, test method development and test method validation (hands‑on execution experience preferred).
• Ability to author technical reports, business correspondence and standard operating procedures.
• Experience with planning and executing process validations (TMV, IQ/OQ/PQ) including authoring of Master Validation Plans and Reports.

• Working knowledge of IEC 62304 and IEC 60601‑1.
• Ability to drive process improvement activities.
• ASQ Certification in Quality or Reliability.
• Ability to multi‑task, prioritize, meet/exceed deadlines and hold themselves, and others accountable.

• Mid‑Senior level

• Contract

• Quality Assurance and Engineering
• Medical Equipment Manufacturing and Biotechnology Research

Referrals increase your chances of interviewing at ATR International by 2x.

Apply BELOW