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Weekly Digest

Senior NPI Engineer at Elegen

Elegen Bio
San Carlos, California, United States
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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.

We are seeking a highly skilled and experienced New Product Introduction (NPI) Engineer to join our Oligo Synthesizer team. The Senior NPI Engineer is responsible for overseeing the successful introduction, production, maintenance, and change control of oligo synthesizers in collaboration with contract manufacturers. The goal is to ensure the seamless deployment of synthesizers to the oligo production team, meeting high-quality standards and project objectives. This role requires strong technical expertise in instrument build and test processes, as well as excellent project management and communication skills.

Key Responsibilities:

  • Lead the NPI process for oligo synthesizers, ensuring a smooth transition from design to deployment.
  • Collaborate with cross-functional teams in R&D and Operations departments to define product requirements and timelines:
  • Enhance synthesizer build and test processes to improve run success rate, reduce hands-on time, and optimize costs.
  • Define and execute comprehensive test strategies and protocols for synthesizer quality and reliability.
  • Interface with contract manufacturers (CM) to manage design for manufacturability (DFM), procurement, build, and validation of synthesizers:
  • Maintain strong relationships, fostering clear communication for project alignment and issue resolution.
  • Establish protocols for outgoing quality control testing at contract manufacturing sites.
  • Conduct acceptance tests, incoming quality control, and hands-on troubleshooting for synthesizers and consumables:
  • Analyze root causes of issues and implement corrective actions to improve product performance and efficiency.
  • Maintain accurate engineering documentation to support manufacturing processes and knowledge transfer.
  • Facilitate the hand-off and training of synthesizers to the oligo production staff, ensuring comprehensive understanding of operation.

Essential Qualifications and Experience:

  • Bachelor’s or Master’s degree in engineering (Electrical, Mechanical, Chemical, or a related field).
  • 3+ years of experience in NPI engineering roles, focus on instrument build, test, and launch.
  • Experience collaborating with contract manufacturers and transitioning projects from R&D to production.
  • Strong understanding of instrument architecture, manufacturing processes, and quality control.
  • Proficiency in engineering documentation, including CAD drawings, BOMs, work instructions, and ECOs.
  • knowledge of quality control principles, statistical process control, and Design of Experiments (DOE).
  • Strong analytical, problem-solving, and decision-making skills.
  • Excellent verbal and written communication skills.
  • Ability to travel domestically and internationally, as required, to collaborate with contract manufacturers and attend project-related meetings or training sessions.

Preferred Qualifications and Experience:

  • Preferred experience in the biotechnology or pharmaceutical industry.
  • Experience with microfluidics is a plus.
  • Proficiency in programming is a plus.

Note: This job description outlines the primary duties and requirements of the position but is not exhaustive. Other tasks and responsibilities may be assigned as needed.

Salary and Benefits:

The annual base salary compensation for this role, if based in California is: $106,000 - $170,000. 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 Employement Laws:

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