Sr. Development Quality Engineer

Role: Sr. Development Quality Engineer

Location: Pleasanton, CA (Onsite)

Duration: 12 Months

Key Responsibilities:

Apply design control processes to support medical device development

Lead risk management activities per ISO 14971

Support design verification and validation (V&V)

Review and create clear, accurate technical documentation

Collaborate with cross-functional teams (R&D, Regulatory, Manufacturing)

Must-Have Skills:

Strong knowledge of FDA QSR and ISO 13485

Hands-on with Design Controls, Risk Management, DFMEA/PFMEA

Experience with Class II/III or combination products

Excellent communication and documentation skills

Understanding of medical device development lifecycle

Software quality experience is a plus

Education:

Bachelor’s degree in Engineering (Biomedical or Mechanical preferred)

Experience:

5–7 years in Quality Engineering for medical devices