Senior Product Development Engineer
QuidelOrtho
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.
Responsibilities
- 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
Requirements
- 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
Compensation: $130,000-$145,000 base, bonus eligible
Vacancy posted 5 days ago
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