Job Description
LexaGene is developing an automated instrument for rapid pathogen detection in human clinical diagnostics, veterinary diagnostics, food safety, and other markets. Join our team as we ramp up for the commercial build of our MiQLab which can quickly detect, at point-of-need, novel infectious diseases like COVID-19 and prevent the spread of future outbreaks.
LexaGene is looking for a motivated, highly creative and broadly skilled Sr. Manufacturing and Quality Engineer to join its fast-growing team to play a key role in developing our pathogen detection platform. You will play a key role in scaling our new products to commercialization and launch. In this role, you will lead manufacturing engineering and scale-up activities for the instrument, reagents, and disposables.
Primary Responsibilities
Work with R&D to transition products from engineering to production
Assist manufacturing and engineering with prototype builds
Create and manage the BOM for the instrument, disposables, and reagents
Develops, evaluates, and improves manufacturing methods; modifies processes to improve safety and product quality, and/or reduce costs
Develop and implement QMS and ISO 13485 – compliant manufacturing documentation including specifications, manufacturing, test and quality procedures, bills of materials, assembly drawings or models
Establish practical calibration and quality measurements and procedures for production transfer
Preferred Qualifications and Experience
Bachelor’s degree in mechanical engineering, product design, industrial design, manufacturing, a relevant field or equivalent practical experience.
8+ years of experience in a wide range of manufacturing processes and technologies
5+ years related experience in Medical Device/ Pharmaceuticals
Understanding of mechanical design, manufacturing and engineering requirements and constraints. Broad range of experience and technical depth that can be applied to a broad range of problems
Track record of a successful working relationship with Engineering, Manufacturing, Supply Chain, and external work partners
Involvement in transitioning a product from engineering prototype to production
Experienced user of SolidWorks or similar CAD software
Experience with ISO 13485/CE Mark requirements. Manufacturing management experience in manufacturing planning, documented systems, GMP, and quality
Strong organizational, problem-solving, and analytical skills
Strong knowledge with ERP/MRP systems
Acute attention to detail
Demonstrated ability to plan and organize projects
Excellent communication skills, verbal and written
Benefits
- Applicants should expect a rapid-growth environment, where there is room for career advancement for talented and driven employees. Industry competitive benefits are offered, including health, dental, vision, 401k, and RSUs.
