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.
San Diego, CA - Flexible work from home schedule.
- Work with the Automation Group to support Lucira Health's Test Kit programs
- Primary responsibility will be to implement novel high volume equipment and processes to support both internal and external manufacturing operations
- Apply technical knowledge to address process challenges with equipment suppliers and quickly deliver high volume commercial operations
- Coordinate and align automated operations with product and process development efforts and program goals, as well as work closely with manufacturing and supply chain, quality engineering, equipment suppliers and contract manufacturing organizations
In this role, the Automation Engineer will
- Develop and implement automated manufacturing equipment for the commercial manufacturing of Lucira Health's Test Kits
- Execute equipment sourcing, documentation, fabrication and qualification at operations sites
- Manage deliverables from equipment manufacturers, material suppliers, and engineering service partners
- Participate in project meetings and prepare project documentation including project summaries to inform management of project status
- Partner with engineering, manufacturing, supply chain, quality and process development teams to realize commercial scale-up goals
- Support the design and development of new products, including participation in design reviews to make sure designs are capable of meeting full scale production
- Coordinate design and technical transfer activities with mfg. engineers and contract manufacturing organizations
- Bachelor's degree in Engineering, or a related field
- 2-5 years of automation or process engineering experience in supporting manufacturing and commercial operations in a regulated environment (pharmaceutical or medical device)
- Experience working with equipment suppliers and equipment deliverables
- Understanding of GMP manufacturing and documentation requirements to ensure rapid product integration into production, specifically equipment transfer and qualification process from R&D to commercial operations
- Familiarity with medical industry equipment regulations, specifically GAMP design philosophy for medical device equipment including FAT, SAT, IQ, OQ, PQ, gauge R&R and measurement analysis
- Experience authoring quality related equipment documentation such as URS, FDS, pFMEAs, qualification protocols and reports
- Competency in high-volume assembly processes including assembly, heat staking, sealing, ultrasonic welding, fluid dispensing, functional test, labeling and visual inspection.
- Knowledge of general automation processes such as machine vision, conveyors, tray handlers, bulk feeders, pneumatics, small part handling, dispensing, sensors and I/O controls
- Proficiency in CAD software, SolidWorks preferred
- Highly proficient with Microsoft Office Suite, including MS project and Visio.
- Superb verbal and written communication skills
- Hands-on individual who enjoys rolling up their sleeves to respond quickly to problems and issues
- Ability to work both independently and collaboratively with small, cross-functional teams
- Likes to travel; up to 25% travel
- Master's degree in Engineering, or a related field
- Lyophilized pellet handling experience
- Familiarity with packaging operation experience including pouching, cartoning, printing, case packing and palletization
- Equipment design experience
- Product development experience, including experience with design control process
- Basic knowledge of electrical circuits
- Experience with machine control systems and machine vision software
- Knowledge of machine shop practices
Lucira Health is an equal opportunity employerand 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.