Principal Quality Engineer

Principal Quality Engineer at BioTalent Principal Quality Engineer at BioTalent in Newark, California Posted in 8 days ago.

Type:

full-time

Job Description:

Principal Design Quality Engineer - Class III Implantable Medical Device San Francisco Bay Area | Full-Time | Hybrid A fast-growing medical device company developing next generation implantable technology is expanding its engineering team and hiring a Staff Design Quality Engineer to support the development of a highly innovative Class III medical device platform. This is a highly technical, hands-on role embedded directly with R D, focused on ensuring quality is built into product development from early feasibility through clinical and commercial stages. You will play a key role in helping bring a breakthrough therapy to market while working alongside experienced engineers and cross-functional leaders in a collaborative development environment. Responsibilities Partner closely with R D and systems engineering teams to integrate design quality into product development Lead and support design control activities throughout the product lifecycle Drive risk management efforts (ISO 14971) including hazard analysis, FMEAs, and risk mitigation strategies Support verification and validation planning and execution Ensure compliance with FDA design control requirements and global quality standards Participate in cross-functional design reviews and technical decision making Help translate regulatory and quality requirements into practical engineering processes Qualifications BS or MS in Engineering (Biomedical, Mechanical, Electrical, or related) 7+ years of experience in medical device product development or design quality Strong experience with design controls and risk management Experience supporting Class II or Class III medical devices Ability to collaborate closely with R D in early-stage product development Experience supporting IDE, PMA, or complex regulatory pathways is highly valued What Makes This Opportunity Unique Work on cutting-edge implantable technology Join a highly technical engineering-driven team Be involved early in the development lifecycle Significant opportunity for technical ownership and influence Competitive compensation, bonus, and equity package If you are interested in learning more, feel free to reach out directly.