Senior Engineer, NPD-Quality
Edwards Lifesciences · Irvine, CA
QualityFull-time$108k–$153kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Senior quality engineer role supporting new product development for cardiac surgical technologies. The position involves managing design control documentation, risk management processes, and cross-functional collaboration to ensure regulatory compliance and product safety throughout the development lifecycle.
What they're looking for
- Bachelor's degree in engineering or science with 4+ years industry experience
- Master's degree in engineering or science with 3+ years industry experience (alternative)
- Ph.D. in engineering or science with industry experience (alternative)
- FDA medical device regulations knowledge
- Proficiency with MS Office Suite and project management tools
- Statistical analysis and problem-solving skills
- Leadership ability and cross-functional team collaboration experience
What you'll be doing
- Create and maintain design control documentation and risk management files throughout product development
- Collaborate with R&D, manufacturing, and clinical teams on design verification, validation, and product launch activities
- Investigate product quality and compliance issues; analyze findings and develop corrective action recommendations
- Optimize manufacturing and R&D processes using engineering methodologies to improve efficiency and reduce risk
- Train and supervise technicians on testing procedures and provide guidance to junior staff
Privacy & handoff
This role links to Edwards Lifesciences's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.