Senior NPI Engineer

4 weeks ago

San Carlos, California, United States Elegen Full time
About the Role

Elegen is a pioneering company in the biology-based economy, leveraging cutting-edge DNA synthesis technology to deliver innovative solutions. As a Senior NPI Engineer, you will play a crucial role in spearheading the development of cutting-edge instruments, collaborating closely with our R&D teams to ensure seamless integration and optimal performance.

Key Responsibilities
  • Collaborate with R&D teams to develop and enhance instrument prototypes, ensuring alignment with design specifications and performance criteria.
  • Conduct comprehensive testing and validation of instrument prototypes, analyzing data and providing actionable feedback to optimize design efficacy.
  • Evaluate manufacturability of instrument designs, identifying potential production hurdles and recommending process enhancements.
  • Generate 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 meticulously 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.
  • 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 in these processes.
  • Strong analytical prowess, coupled with adept problem-solving and decision-making skills, enabling effective resolution of complex engineering challenges.
  • Self-motivated, with a passion for continuous learning and the ability to swiftly grasp new concepts, fostering autonomy in task execution while contributing effectively within a team environment.
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.
About Elegen

Elegen is a well-capitalized company, backed by top life science investors, including Andreessen Horowitz, 8VC, and KdT. Our team is advised and staffed by leading biotechnology scientists and entrepreneurs, including Dr. Marc Unger, inventor of the NanoflexTM valve, and former CSO of Fluidigm. We are committed to advancing innovative technologies from invention to commercial success.

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