QA Validation Engineer
Exactech
Principal Engineer – Head of Sensor Production Support
Dexcom
full-time
Posted on:
Origin: • 🇺🇸 United States • California
Visit company websiteSalary
💰 $181,000 - $301,600 per year
Job Level
Lead
About the role
- Lead the development and implementation of improvements to current sensor products.
- Identify, prioritize, and drive implementation of design and process improvements that enhance quality, reliability, cost, and manufacturability of on-market sensor products.
- Lead structured root‑cause investigations and failure analyses; define, verify, and sustain robust CAPA.
- Partner closely with Quality, Sustaining, and Operations Engineering to assess field performance data and execute continuous improvement projects.
- Support production scale‑up, second‑source qualification, and change control in accordance with design controls and quality system requirements.
- Support New Product Introduction (NPI) activities to ensure successful planning, implementation and design transfer and scale-up.
- Present yourself as a role model for leadership behavior: communicate and collaborate effectively, be dependable, develop talent, and champion long‑term strategy.
Requirements
- Deep expertise in sensor technologies, high volume manufacturing, test measurement techniques and systems, and functional requirements and characterization best practices.
- Proven experience driving complex product and process improvements within regulated medical device environments (e.g., FDA, ISO 13485).
- Demonstrated ability to lead through influence in a matrixed organization; adept at risk management, tradeoff decisions, and execution under ambiguity.
- Strong analytical and statistical skills (e.g., DOE, SPC, root‑cause methods) and familiarity with process validation (IQ/OQ/PQ).
- Excellent communication skills – verbal, written, and presenting technical material.
- Typically requires a Bachelor’s degree in a technical discipline and a minimum of 15+ years related experience OR a Master’s degree and 10+ years OR a PhD and 7+ years of experience.
- Ability to support production scale‑up, second‑source qualification, and change control in accordance with design controls and quality system requirements.
- Experience supporting New Product Introduction (NPI) activities.
- Willingness to travel 5-15%.
