Senior NPI Engineer

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, microfluidics, and pneumatic components and systems, showcasing a comprehensive skill set in managing these crucial elements.
• Demonstrated competence in life cycle management for software, including validation, upgrade, and deployment processes, ensuring the seamless operation and continuous enhancement.
• Prior engagement within a startup environment.

Salary and Benefits:

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

✓ Healthcare ✓ Dental ✓ Vision ✓ Learning Allowance

✓ 401K ✓ Flexible PTO ✓ Short Term Disability ✓ Fitness Allowance