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.
This position will join the Company's team to manage production projects with contract manufacturers for instrument products. This individual will work closely with many functional teams as well as counterparts from the contract manufacturers to ensure effective technology transfer and establish successful instrument manufacturing capability. The successful candidate will:
- Assume primary responsibility for managing the contract manufacturers
- Manage the technology transfer projects from R&D engineering team to operations
- Coordinate with Product Development and Molecular biology teams on assay, reagent and material requirements for the instrument products
- Coordinate 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
- Assume responsibility to lead the contract manufacturers to a reliable operational state, track key process indicators & analysis to ensure product quality and lead improvement initiatives
- Assist engineering team with communicating and developing released documentation formats and standards for efficient manufacturing release.
- Review product designs for manufacturability and give input on design changes for improved contract manufacture assembly time and yield.
- Work with contract manufacturers to update engineering fixtures or create new assembly fixtures and tooling, as required to meet production capacity and process quality goals.
- Coordinate with contractors, and manage validation testing and release of any cost reduction and yield improvements required for released products.
- BS or MS in Engineering with 10+ years of experience with 5 years working in the medical device & instrument field
- 5 years direct working experience in manufacturing engineering, process development or instrument product engineering with demonstrated tech transfer and supplier management capabilities.
- Direct experience or involvement in supply chain management
- Knowledgeable and proficient working with PLM systems and developing schedules, BOM management, inventory management, change orders, document control, etc..
- Hands-on experience with SPC and statistical analysis tools including Minitab
- Experience working in GMP environment and 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.
- Excellent communications skills and demonstrated ability to collaborate with cross-functional teams
- Experience working with Arena PLM products is desirable