Senior Medical Device Quality Engineer – Design & Risk

SPECTRAFORCE; Pleasanton (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading healthcare company in Pleasanton is seeking a Sr. Quality Development Engineer for a 6-month contract. This role involves providing quality expertise, supporting product development, and ensuring compliance with FDA regulations. The ideal candidate has 5+ years in R&D or Quality, preferably in medical devices, and strong experience in test method development and risk management. This position offers an opportunity to collaborate closely with various teams to contribute to product safety and quality.

Qualifications

• Minimum of 5 years of experience in R&D, Process/Manufacturing Engineering, and/or Quality.
• Experience in preparing risk assessments, FMEA, and other risk documents.
• 3 – 5 years of medical device (non-software) experience.

Responsibilities

• Lead and/or support on-time completion of Design Control deliverables.
• Support the establishment of objective, measurable, and verifiable product requirements.
• Comply with the client’s U.S. FDA, EUMDR, and other requirements.

Skills

Experience in medical devices

Test method development

Risk management

Education

Bachelor’s degree in Engineering or Technical Field

Advanced Degree in Engineering/Technical Field

Tools

JIRA

Requirements management tools (e.g., DOORS)

Job description

A leading healthcare company in Pleasanton is seeking a Sr. Quality Development Engineer for a 6-month contract. This role involves providing quality expertise, supporting product development, and ensuring compliance with FDA regulations. The ideal candidate has 5+ years in R&D or Quality, preferably in medical devices, and strong experience in test method development and risk management. This position offers an opportunity to collaborate closely with various teams to contribute to product safety and quality.