Senior NPI Engineer (Instruments)

Elegen is blazing a path towards a biology-based economy with a highly innovative approach to DNA synthesis that delivers an industry leading length of 7kb in 7 business days with a 99.999% per base accuracy. Our multidisciplinary team of best-in-class biologists, chemists, hardware, and software engineers apply cutting-edge technologies and methods to solve critical bottlenecks in synthetic biology workflows to help our customers in pharma, biotech, agbio, and biomanufacturing streamline their work and realize the full potential of programmable biology.

This is an opportunity to join a rapidly growing company at an early stage and to have an impact on the development of its products, markets, processes, people, and culture.

We are in search of a highly skilled and seasoned Senior NPI Engineer to bolster our NPI engineering team. In this role, the Senior NPI Engineer will collaborate closely with our R&D teams to spearhead the development of cutting-edge instruments. Their responsibilities will span from initial construction and testing to installation and qualification. Furthermore, the Senior NPI Engineer will play a pivotal role in supporting our production efforts, contributing to equipment upgrades, maintenance activities, and troubleshooting endeavors.

This presents a rare and thrilling opportunity for a Senior NPI Engineer eager to thrive in a uniquely innovative, fast-paced startup environment. Beyond the exciting prospect of contributing to the development of groundbreaking instruments, you will play a pivotal role in cultivating a culture defined by mutual respect, integrity, and collaboration. Joining forces with some of Silicon Valley's top scientists and engineers, you'll embark on a journey of growth and excellence.

 Essential Responsibilities:

• Collaborate closely with R&D teams to iteratively develop and enhance instrument prototypes, ensuring they align precisely with design specifications and performance criteria.
• Conduct comprehensive testing and validation of instrument prototypes, meticulously analyzing resulting data and furnishing actionable feedback to optimize design efficacy.
• Evaluate the manufacturability of instrument designs, pinpointing potential production hurdles and avenues for process enhancement, then offering DFX (Design for Excellence) recommendations.
• Generate and maintain up-to-date Bill of Materials (BOM), CAD models, schematics, and assembly drawings for effective material procurement and streamlined communication with internal and external stakeholders.
• Draft IQ/OQ/PQ protocols and reports, actively 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 in their proficient execution.
• 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 also providing comprehensive training to technicians and operators on execution and documentation protocols.
• Effectively manage spare parts inventory, assuming responsibility for procurement and meticulous storage to ensure uninterrupted operational continuity.

 Essential Qualifications and Experience:

• Bachelor’s degree in mechanical, electrical, or biomedical engineering, coupled with a minimum of 5 years' experience in NPI or manufacturing engineering, with a preference for specialization in instrumentation.
• Expertise in SolidWorks, demonstrating 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 necessary for effective operations.
• Prior hands-on experience in equipment operation, testing, maintenance, and troubleshooting, highlighting a comprehensive understanding of the intricacies involved in these processes.
• Possession of 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 and Experience:

• Previous involvement in life science instrument NPI engineering.
• Proficient in the installation, upkeep, and replacement of fluidics, micro