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NPI Engineer (Consumables)



San Carlos, CA, USA
Posted on Friday, May 17, 2024

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 actively seeking a proficient and committed NPI Engineer to join our team. In this role, the selected candidate will be responsible for a diverse range of tasks, including the assembly of microfluidics chips, meticulous inspection and preparation of consumables, and the formulation of comprehensive manufacturing and test protocols. Moreover, they will assume the pivotal role of becoming the consumables subject matter expert, overseeing crucial aspects such as procurement, material disposition, root cause analysis, and the qualification of new materials.

This presents a rare and thrilling chance for an NPI engineer eager to glean insights from a stellar team of engineers and scientists, while flourishing within a uniquely innovative, fast-paced, high-impact startup environment. Your contributions will not only aid in our growth but also play a pivotal role in fostering a culture of mutual respect, integrity, and collaboration. Join us as we collaborate with some of Silicon Valley's finest scientists and engineers, embarking on a journey of innovation and excellence.

Essential Responsibilities:

  • Oversee consumable inspection, preparation, and assembly throughout phases 3 & 4 until transitioned to the operations team or outsourced.
  • Develop comprehensive standard operating procedures (SOPs), work instructions, and manufacturing/test procedures. Additionally, conduct training sessions to ensure personnel are proficient in these protocols.
  • Apply advanced data analysis techniques to interpret experimental results, discern emerging trends, and drive data-informed decisions aimed at optimizing consumable preparation processes.
  • Lead the design and execution of experiments, author detailed protocols, conduct rigorous feasibility studies, and generate comprehensive reports to evaluate both existing and new materials for production suitability.
  • Conduct thorough reviews of material non-conformances, execute root cause analyses, and implement effective corrective and preventive actions to uphold product quality.
  • Identify and capitalize on opportunities for process optimization and cost reduction through strategic material selection, continuous process refinement, and collaborative engagement with suppliers.
  • Foster robust and collaborative relationships with suppliers, serving as the primary liaison for effective communication and issue resolution. Proactively seek out and qualify new suppliers as needed to diversify sourcing options and mitigate risks.
  • Assume accountability for consumables procurement, including an oversight of storage and proactive inventory management practices to ensure seamless supply chain operations.

Essential Qualifications and Experience:

  • Bachelor’s degree in mechanical, chemical, biomedical engineering, or physics, accompanied by a minimum of 2 years of experience in NPI or manufacturing engineering, with a preference for specialization in consumables.
  • Demonstrated proficiency in crafting engineering documentation including SOPs, WIs, protocols, BOMs, reports, and other essential documents necessary for effective operations.
  • Proven expertise in experimental design, statistical analysis, and adeptness in interpreting and presenting data.
  • Possession of strong analytical prowess, coupled with a keen problem-solving aptitude, enabling the resolution of complex challenges encountered in engineering endeavors.
  • 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.
  • Must be willing to travel up to 15% of the time for meetings with contract manufacturers and to support other business-related activities.

Preferred Qualifications and Experience:

  • Demonstrated track record of effectively managing supplier relationships and overseeing contract manufacturers to ensure seamless collaboration and optimal performance.
  • Proven familiarity and prior hands-on experience working with glass capillary tubes, showcasing proficiency in their handling and application within relevant contexts.
  • Advanced expertise in statistical methodologies including correlation analysis, hypothesis testing, variance analysis, CPK (Process Capability Index), PPK (Process Performance Index), and Gage R&R (Gauge Repeatability and Reproducibility), facilitating data-driven decision-making and process optimization.
  • Prior engagement within a startup environment.

Salary and Benefits:

The annual base salary compensation for this role, if based in California is: $115,000 - $145,000. 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

About The Company:

Founded and led by Dr. Matthew Hill and located in San Carlos, CA, Elegen is well-capitalized by top life science investors, including Andreessen Horowitz, 8VC, and KdT. The company is advised and staffed by leading biotechnology scientists and entrepreneurs, including Dr. Marc Unger, inventor of the Nanoflex™ valve, and former CSO of Fluidigm. Dr. Hill has a PhD from Stanford and a proven track record of advancing innovative technologies from invention to commercial success. Over eight years in his previous role as VP of R&D at a leading molecular diagnostics company, he co-invented and launched five precision molecular diagnostic products, including a best-in-class noninvasive prenatal test used by millions. These products earn more than $350 million per year in revenue and enabled an IPO.

Elegen is an Equal Opportunity Employer.

Elegen provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic characteristics, or any other category protected by law. All applicants have rights under the following Federal Employment Laws: