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Senior NPI Engineer

2 months ago


San Carlos, California, United States Elegen Full time

About the Role:

We are seeking a highly skilled and experienced Senior NPI Engineer to join our team at Elegen. As a Senior NPI Engineer, you will play a critical role in the development and launch of our cutting-edge life science instruments. Your expertise will be instrumental in ensuring the successful design, testing, and validation of our products.

Key Responsibilities:

  • Collaborate closely with our R&D teams to develop and enhance instrument prototypes, ensuring they meet design specifications and performance criteria.
  • Conduct comprehensive testing and validation of instrument prototypes, analyzing data and providing actionable feedback to optimize design efficacy.
  • Evaluate the manufacturability of instrument designs, identifying potential production hurdles and recommending process enhancements.
  • Develop and maintain up-to-date Bill of Materials (BOM), CAD models, schematics, and assembly drawings for effective material procurement and communication with stakeholders.
  • Draft IQ/OQ/PQ protocols and reports, participating in equipment installation and production qualification activities to ensure compliance and operational readiness.
  • Develop and refine Standard Operating Procedures (SOPs), work instructions, and test procedures, conducting comprehensive training sessions to empower operators and technicians.
  • Diagnose and troubleshoot malfunctioning instruments, leveraging root cause analysis methodologies to implement targeted corrective and preventive measures.
  • Formulate equipment calibration schedules and preventive maintenance plans, executing them while providing comprehensive training to technicians and operators.
  • Effectively manage spare parts inventory, assuming responsibility for procurement and storage to ensure uninterrupted operational continuity.

Requirements:

  • Bachelor's degree in mechanical, electrical, or biomedical engineering, with a minimum of 5 years' experience in NPI or manufacturing engineering, preferably in instrumentation.
  • Expertise in SolidWorks, with proficiency in utilizing this software for design and engineering tasks.
  • Proficient in crafting engineering documentation, including SOPs, WIs, protocols, BOMs, reports, and other essential documents.
  • Prior hands-on experience in equipment operation, testing, maintenance, and troubleshooting, highlighting a comprehensive understanding of the intricacies involved.
  • Possession of strong analytical prowess, coupled with adept problem-solving and decision-making skills, enabling effective resolution of complex engineering challenges.

Preferred Qualifications:

  • Previous involvement in life science instrument NPI engineering.
  • Proficient in the installation, upkeep, and replacement of fluidics, microfluidics, and pneumatic components and systems.
  • Demonstrated competence in life cycle management for software, including validation, upgrade, and deployment processes.
  • Prior engagement within a startup environment.

Compensation and Benefits:

The annual base salary compensation for this role is: $133,000 - $153,000. Compensation may be different in other locations. Final compensation includes bonus, equity, and benefits. Specific offer packages are determined by multiple factors, including candidate skill, experience, expertise, and location.

About Elegen:

Elegen is a well-capitalized life science company, advised and staffed by leading biotechnology scientists and entrepreneurs. Our company is committed to advancing innovative technologies from invention to commercial success.