Lucira Health
  • Emeryville, CA, USA
  • Full Time

About Lucira Health

Lucira Health is a medical technology company focused on the development and commercialization of transformative infectious disease test kits. We have developed a testing platform that produces centralized-laboratory-accurate molecular testing in a single-use and consumer-friendly test kit that is powered by two AA batteries and fits in the palm of a hand. Our LUCIRA Check It (OTC) and LUCIRA COVID-19 All-In-One Test Kit (Rx) are designed to provide a clinically relevant COVID-19 result within 30 minutes from sample collection.

Location

Emeryville, CA - Hybrid

Summary

The Lead Sustaining Engineer on the R&D Engineering team at Lucira Health, Inc. will work with cross-functional R&D, Process Development and Quality teams to implement continuous improvements to Lucira Health products. You will manage a team responsible for implementing design changes motivated by automation, supply chain or cost reduction, resolving manufacturing defects and customer complaints, and designing equipment for internal use in manufacturing and product development.

Responsibilities

  • Manage a team of 3-5 engineers, while providing technical guidance, setting objectives, and fostering professional development
  • Lead projects to troubleshoot systemic reliability issues, identify solutions, regression test those solutions, and implement them into production
  • Implement design changes to facilitate automation, improve supply chain, and reduce cost
  • Provide technical guidance to NCRs and CAPAs, including leading root cause investigations and providing input on functional impact of nonconformances
  • Perform tolerance stack up analysis and implement design changes to improve design robustness
  • Oversee design, assembly, and maintenance of internal equipment and fixtures
  • Coordinate design transfer activities with manufacturing engineers and contract manufacturers
  • Contribute to manufacturing process development in collaboration with manufacturing engineers, quality engineers, and vendors
  • Follow established design control procedures including leading design reviews, writing and approving Engineering Change Requests, and performing risk management activities

Qualifications

  • Bachelor's Degree in Mechanical, Biomedical Engineering, or a related field
  • 10+ years engineering experience in a medical device company
  • Experience in Solidworks CAD modeling
  • Experience in PDM/PLM systems
  • Exposure to design for injection molding & plastic part design
  • Experience in statistical data analysis methods and experimental design
  • Familiarity with design control requirements per 21 CFR 820 and ISO 13485
  • Strong project management skills and interpersonal, relationship-building skills
  • Experience managing an engineering team is preferred
  • Excellent oral and written communication skills

Lucira Health is an equal opportunity employer and is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status or any other consideration made unlawful by federal, state or local law.


Lucira Health
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