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Senior Product Development Engineer

$130k - $145k

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 a month ago
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