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Process Engineering Associate

About us: Lucira Health is a startup striving to transform the way infectious diseases are diagnosed. Lucira Health is the first at-home COVID test authorized by the FDA. Our technology is a single-use, user-friendly COVID test kit that can produce a positive or negative result at home within 30 minutes. This technology bypasses centralized medical lab testing and streamlines patient care. Our current areas of focus include COVID and influenza.


Description:

As Process Engineering Associate atLucira Health, Inc., you will be responsible for planning and performing qualification of high-volume injection molded parts. This position will be expected to work closely with the mold vendor(s) as well as the internal Lucira team to establish protocols for measuring and testing injection molded plastics parts for tooling validation. This position will work closely with R&D to define critical dimensions and attributes as they relate to product performance.


Primary Job Function:

This position will work cross functionally with other functions of our organization to achieve corporate milestones. 

  • Perform testing of injection molded parts to qualify new high cavitation mold tools.
  • Design fixtures to assist in scaling up QC inspection of plastic parts.
  • Write IQ/OQ/PQ test plans in accordance with FDA and regulatory guidelines.
  • Perform validation of testing equipment and fixtures.
  • Document Validation protocols
  • Perform measurements of critical part dimensions to define specification and tolerances.
  • Program, test and validate optical measurement programs.
  • Initiate, design and build test fixtures to test or evaluate components
  • Ability to work with suppliers and molding houses on key component issues as it relates to manufacturing to implement process controls Ability to work cross functionally and communicate effectively, verbally and written to a broad audience
  • Create and maintain project scheduled with regards to mold tool builds and work with the tool builder to stay on schedule.
  • Visit vendor as needed to evaluate molding and tool build capabilities.


Qualifications:

  • Requires a BS in Engineering or GED with 8+ years of industry experience.
  • Medical device manufacturing experience essential; injection molding and plastic part assembly, metal machining.
  • Experience with high volume injection molding and tooling validation.
  • Experience in mold tooling qualification
  • Understanding of basic GD&T Principals/Experience with Optical Measurement System Programming. Experience with Micro-Vu system is preferred.
  • Knowledge of ISO, FDA, UL and CE requirements as they relate to tooling as process validation.
  • Proficient with Solidworks, Minitab or equivalent, Microsoft Project, PowerPoint, Word and Excel.
  • Experience performing Gauge R&R is a plus.
  • Proficient experience in applying DFSS/Lean Six Sigma elements into Manufacturing problems
  • Knowledge of machine shop practices desirable
  • Must be self-motivated and be able to work independently as well as in a group environment.
  • Must be a hands-on problem solver. Must have demonstrated cross-functional team effectiveness, excellent interpersonal and written communication skills.


Lucira Health is an Equal Opportunity Employer
Individuals seeking employment at Lucira Health are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation.


Job Category: Manufacturing
Job Type: Full Time
Job Location: 1412 62nd St. Emeryville CA 94608

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