Job Title: Quality Engineer

Location: Pleasanton, CA

Duration: 12 Months

Job Description:

Key Responsibilities:

• Support the preparation of regulatory submission documentation
• Conduct risk analysis and implement appropriate risk controls in line with regulatory standards

Technical Qualifications:

• Proficiency in Engineering methodologies
• Strong command of requirements management and risk management processes
• Familiarity with regulatory standards including IEC 60601 and IEC 62304
• Experience supporting regulatory submissions for Class III medical devices

Education & Experience:

• Bachelor’s or Master’s degree in Biomedical Engineering, Electrical Engineering, Computer Science, or a related technical discipline
• Minimum of 4–5 years of experience in the medical device industry
• Experience with cardiovascular devices is a plus
• Prior work with Class III medical devices is strongly preferred