Staff Quality Engineer, Design Quality - Pleasanton, CA

We are seeking a skilled and detail-oriented Staff Quality Engineer to join our New Product Development (NPD) team. This role is responsible for ensuring that our Class-II new products meet the highest quality standards throughout the development process, from concept to commercialization.

Requirements

• Bachelor’s degree in Engineering, Biomedical Engineering, Mechanical Engineering, Systems Engineering or a related technical field.
• Minimum 10 to 12+ years of experience in quality engineering within the medical device industry, with strong record of being a vital part of NPD launch.
• Strong knowledge, applications, and subject matter expertise of ISO 13485, ISO 14971, IEC 62304 and FDA 21 CFR Part 820.
• Excellent presentation skills and proactive leading mindset. Effective communication, collaborative attitude, and strong accountability mindset.
• Detailed understanding of design controls, risk management, and process validation in the context of medical device development from concept to feasibility to V&V to design transfer to launch.
• Experience with systems design verification and validation (V&V) activities, including support for development of test protocols and reports.
• Hands-on experience working with FMEA tools (design, software, user).
• Excellent problem-solving skills, with the ability to analyze complex technical issues and develop effective solutions. Proficient in statistical tools applications such as Minitab, Jump etc.
• Detail-oriented, with a commitment to producing high-quality work and maintaining rigorous documentation.
• Certifications such as ASQ CQE (Americal Society for Quality Certified Quality Engineer), ASQ CSQE (Certified Software Quality Engineer), Six Sigma Black Belth or similar are a plus.

Benefits

• 401(k)
• Healthcare insurance
• Paid time off
• Stock options – ownership and a stake in growing a mission-driven company