Senior Manufacturing & Quality Engineer


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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.