ABOUT YOU:

In this Technical role, you will be responsible for the transfer of new products from engineering and point of care medical device development into manufacturing, designing, and developing assembly processes that assure the consistent and cost-effective production of high-quality, repeatable assemblies in prototypes through manufacturing scale-up and steady-state production in a cGMP environment. This will include investigating and assessing different assembly processes, developing, implementing, and maintaining processes and automated equipment for the prototyping, scale-up and production, sub-assemblies, and final assemblies incorporating reagents with molded plastic components. Developing process flow maps and optimal assembly sequences, based on the application of lean principles, as well as investigating, evaluating, and recommending new processes and equipment, Make/Buy recommendations, and transferring to third-party vendors as appropriate.

• Execute the transfer of manufacturing processes and technologies from Research and Process Development groups into a cGMP environment.
• Design the appropriate manufacturing processes, define and conduct process development activities and provide design transfer inputs required as part of Tech Transfer;
• As the manufacturing Subject Matter Expert, identify potential risks, evaluate impacts of manufacturing process steps and raw materials on product performance, and develop risk mitigations as part of the tech transfer and scale-up.
• Interface with Engineering teams to define and establish manufacturing and inventory control processes for instruments.
• Establish appropriate manufacturing processes and controls to create and maintain consistency and quality of manufacturing from prototype through production scale-up.
• Utilize your knowledge and experience to develop, assess, implement, and continually enhance cGMP manufacturing processes and operations.
• Lead comprehensive validation activities including planning and execution of validation protocols for equipment, facilities, and processes.
• Identification, procurement, installation, qualification (IQ, OQ, PQ), and maintenance of critical manufacturing equipment.
• Create and maintain cGMP manufacturing documentation (e.g. Work Instructions, in-process, and final acceptance plans and records);
• Support the creation and maintenance of Standard Operating Procedures (SOPs) for ISO13485 and cGMP processes.
• Perform Root Cause Analysis of manufacturing failures, in collaboration with cross-functional team members, to determine failure causes, and define and implement improvements to address the causes of failures.
• Drive Continuous Improvement in manufacturing by identifying improvement opportunities and developing and implementing process improvements.