Full-Time

Senior NPI Engineer

Instruments

Posted on 12/6/2024

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

You match the following Elegen's candidate preferences

Employers are more likely to interview you if you match these preferences:

Degree
Experience
Requirements
  • Bachelor’s degree in mechanical, electrical, or biomedical engineering
  • Minimum of 5 years' experience in NPI or manufacturing engineering, with a preference for specialization in instrumentation
  • Expertise in SolidWorks
  • 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
  • Strong analytical prowess, coupled with adept problem-solving and decision-making skills
  • Self-motivated, with a passion for continuous learning and the ability to swiftly grasp new concepts
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
Desired Qualifications
  • Previous involvement in life science instrument NPI engineering
  • Proficient in the installation, upkeep, and replacement of fluidics, microfluidics, and pneumatic components and systems
  • Demonstrated competence in life cycle management for software, including validation, upgrade, and deployment processes
  • Prior engagement within a startup environment

Elegen focuses on improving the DNA manufacturing process within the synthetic biology sector. The company provides custom DNA synthesis services to researchers, biotech companies, and pharmaceutical firms that need high-quality synthetic DNA for various applications, including biomanufacturing and mRNA-based treatments. Elegen's services are characterized by fast turnaround times and high accuracy, which are essential for clients' research and development needs. Unlike many competitors, Elegen offers an Early Access Program that allows select innovators to access new DNA technologies early, fostering strong relationships and creating additional revenue. The goal of Elegen is to streamline DNA production, reduce costs, and support the development of advanced therapeutics, positioning itself as a significant contributor to the growth of the bioeconomy.

Company Stage

Series B

Total Funding

$34M

Headquarters

San Carlos, California

Founded

2017

Growth & Insights
Headcount

6 month growth

3%

1 year growth

-1%

2 year growth

0%
Simplify Jobs

Simplify's Take

What believers are saying

  • Elegen raised $35M to expand its ENFINIA™ DNA product line for clinical development.
  • Collaboration with GSK enhances Elegen's cell-free DNA technology for vaccines and medicines.
  • Elegen's ability to synthesize complex DNA sequences gives it a competitive market edge.

What critics are saying

  • Increased competition from companies like Twist Bioscience in DNA synthesis capabilities.
  • Potential intellectual property disputes could impact Elegen's proprietary technologies.
  • Dependence on key partnerships, like GSK, could affect market position if dissolved.

What makes Elegen unique

  • Elegen's ENFINIA™ DNA offers rapid synthesis of highly complex DNA in 10 days.
  • The company provides cell-free DNA production, reducing contamination risks and improving efficiency.
  • Elegen's Early Access Program allows clients early access to high-complexity DNA breakthroughs.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

401(k) Retirement Plan

401(k) Company Match

Unlimited Paid Time Off

Short Term Disability

Long Term Disability

Parental Leave

Commuter Benefits

Fitness Allowance

Learning Allowance

INACTIVE