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. We're a growing team and have exciting job opportunities available right now.
Emeryville, CA - Flexible work from home schedule
As Process Engineering Associate at Lucira 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.
In this role, the Process Engineering Associate will:
- 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.
- 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 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.