Senior Operations Engineer-Instruments
This is a medical diagnostics company developing an innovative, new class of platform to enable rapid, high-complexity testing across a wide range of healthcare settings.
Our visionary team combines depth of experience with passion to deliver a pioneering solution to infectious disease diagnostics. Our tests will enable caregivers to know within minutes, the cause of illness, as well as which medications will be effective for their patient, empowering them to provide individualized care rather than broad, guideline-dictated treatments. From the doctor’s office to the hospital bedside to remote care settings, we are re-defining the treatment of infectious diseases.
Our Key Area of Expertise:
- Molecular biology and chemistry
- Bioinformatics/ Assay Design
- End-to-end platform engineering
- Microfluidic chip technology
- System integration and scale up
This company is committed to excellence in advancing improved health outcomes. This commitment, along with a dynamic team culture, drives our mission to develop and commercialize novel approaches.
- As a key member of our Operations team, you will manage production projects focused on our instrument products. Ensure successful technology transfer and establish successful instrument manufacturing capability.
- Manage contract manufacturers and transfer technology projects from R&D engineering to Operations
- Work with the Operations team to meet capacity, throughput, yield and cost requirements
- Develop and manage manufacturing project plans to support product development and commercialization schedules
- Develop and execute validation plans for facility, equipment and processes required to manufacture product instruments
Education & Experience
- BS in Engineering with 7-10 years experience or MS in Engineering with 5-7 years experience - in the medical device & instrument field
- Solid track record of manufacturing engineering, process development and/or instrument product engineering
- Proficient working with PLM systems and developing schedules, BOM management, inventory management, change orders, document control, etc.
- Experience working in GMP environment and with 21 CFR 820 Quality System Regulations
- Technical knowledge and development experience with micro-fluidic devices & instruments, optical design, heat transfer, pneumatics and electro-mechanical devices.
- Experience working with Arena PLM products desirable