Full-Time

Senior NPI Engineer

Instruments

Posted on 10/10/2024

Elegen

Elegen

51-200 employees

Custom DNA synthesis for biotech applications

Biotechnology
Healthcare

Compensation Overview

$140k - $155kAnnually

+ Bonus + Equity + Benefits

Senior

San Carlos, CA, USA

Category
Design Engineering
Manufacturing Engineering
Mechanical Engineering
Required Skills
CAD
SolidWorks
Requirements
  • 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.
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.

Elegen focuses on improving the process of manufacturing synthetic DNA to meet the needs of the bioeconomy. The company provides custom DNA synthesis services to researchers, biotech companies, and pharmaceutical firms that require high-quality and complex synthetic DNA for various applications, including biomanufacturing and mRNA-based treatments. Elegen uses advanced technologies to ensure fast turnaround times and high accuracy in DNA synthesis, which are essential for its clients' projects. Unlike its competitors, Elegen not only streamlines traditional DNA manufacturing workflows but also enables the production of valuable biologics and therapeutics. The company's goal is to support the development of next-generation medicines and drive advancements in the synthetic biology and biomanufacturing sectors.

Company Stage

Series B

Total Funding

$34M

Headquarters

San Carlos, California

Founded

2017

Growth & Insights
Headcount

6 month growth

17%

1 year growth

42%

2 year growth

117%
Simplify Jobs

Simplify's Take

What believers are saying

  • Elegen raised $35M to expand its ENFINIA™ DNA product line for clinical development.
  • Partnership with GSK enhances Elegen's technology for vaccines and medicines.
  • Growing demand for synthetic DNA in personalized medicine boosts Elegen's market potential.

What critics are saying

  • Increased competition from emerging synthetic biology startups threatens Elegen's market share.
  • Rapid technological advancements may outpace Elegen's current capabilities, requiring continuous R&D.
  • Potential supply chain vulnerabilities in microfluidic components could impact production.

What makes Elegen unique

  • Elegen's ENFINIA™ DNA offers rapid synthesis of highly complex DNA in 10 days.
  • The company specializes in cell-free DNA manufacturing, reducing contamination risks.
  • Elegen's Early Access Program provides clients with exclusive access to DNA breakthroughs.

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