Senior Product Development Engineer
QuidelOrtho · Summers Ridge, CA
Medical DeviceFull-time$130k–$145kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
QuidelOrtho seeks a Senior Product Development Engineer to lead point-of-care diagnostic product development from concept through manufacturing scale-up. The role involves designing consumable tests, integrating assays with instruments, managing technology transfer, and ensuring regulatory compliance in a collaborative R&D environment.
What they're looking for
- Bachelor's degree with 7+ years experience or Master's degree with 5+ years in engineering discipline
- Proven experience developing consumable diagnostic tests
- Ability to evaluate technical decisions considering regulatory, technical, and business factors
- Recognized expertise in one or more product design areas
- Demonstrated track record of implementing process improvements and productivity enhancements
- Medical device or diagnostics experience in regulated environments (preferred)
- U.S. work authorization; visa sponsorship not available
What you'll be doing
- Design, develop, and transfer new diagnostic products into manufacturing operations
- Communicate project status, challenges, and resource needs to management regularly
- Write technical documentation, validation protocols, and maintain detailed project records
- Collaborate with R&D scientists to develop, automate, and integrate assays with instruments
- Ensure manufacturing processes are robust, scalable, cost-effective, and compliant with regulatory requirements
Privacy & handoff
This role links to QuidelOrtho'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.