Manufacturing Process Engineer
4 weeks ago
Responsibilities:
Collaborate directly with contract manufacturing partners to support scale-up efforts on our AST Panel manufacturing program.
Travel to contract manufacturing partners as necessary to provide system support during validation, maintenance, and optimization activities.
Collaborate cross-functionally within our organization with Engineering, Chemistry, and Microbiology teams during product development, Quality for product and process documentation, V&V and Regulatory teams during product validation, and Operations for continued product support and improvement.
Manage PM, repair, and inventory of spare parts for the panel manufacturing line.
Work with Planning lead and Supply Chain Management to understand forecasts and develop production schedules with Contract Manufacturers.
Provide support as necessary to develop and perform validation and verification for activities.
Develop and report on KPIs of the panel manufacturing program.
Remain current on cGMP and FDA guidelines as related to medical devices.
About Selux: We are a diagnostics company dedicated to preserving the lifesaving efficacy of antibiotics. Our mission is to provide diagnostic results in hours, rather than days, and we are building a multidisciplinary team of talented individuals to help achieve this mission. Joining our team will give you an opportunity to harness your talent and advance your career by working in diverse groups of high-performing teammates tackling the most important healthcare challenges. We offer a competitive benefits package, including healthcare, 401K match, stock option grants, open paid time off, and supportive family leave policies. Vaccination for COVID-19 is a requirement of employment. We are proud to be an inclusive workplace and an Equal Opportunity Employer.
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