Essential Responsibilities: • Support prototype, V+V and commercial production of disposable medical devices in coordination with the Operations, Product Development and Quality Assurance organizations. • Provide production floor support, generating & soliciting process improvement ideas from production operators and R&D engineers, prioritizing impact based on potential for yield improvement, COGs reduction and overall ROI and leading implementation into production. • Develop and maintain process documentation including assembly procedures, test procedures, equipment specifications, component specifications, BOMs, process flows, and process FMEAs. • Analyze process trend data and communicate issues based upon a data driven approach. Identify opportunities for process improvements using Six Sigma and Lean Manufacturing tools. • Support and enforce company goals and objectives, policies and procedures, Good Manufacturing Practices, Good Documentation Practices, FDA QSR and ISO regulations. Knowledge of FDA QSR and ISO regulations required. • Identify and execute process validations including generation of plans, protocols and reports. • Qualify and optimize processes and tooling via IQ/OQ/PQ, Gage R&R Studies, Process Capability Studies and Designs of Experiments. • Ability to work in a cross-functional team in a startup environment. Highly effective communicator of technical status and issues required. Must enjoy team approach over individual contributions. • Regularly report on project status, schedule progress updates and use key project metrics in presentations, action items and meeting minutes with program and operations management. • Participate in the investigation of failures and formulation and implementation of action plans for all internal corrective actions, audit findings. Address WIP and Incoming MRB in a timely manner. • Maintain accurate documentation of concepts, designs, and processes while maintaining current knowledge of medical, technical, and biomedical developments as related to Spryte products. • Work with product development staff to ensure that products under development are designed for manufacture, test, and inspection as appropriate.
Experience & Qualifications: • Minimum of 5 years of related work experience desired. Medical device experience preferred. • Knowledge of FDA QSR and ISO regulations required. • Ability to Communicate ideas and information clearly, effectively, and frequently (oral and written) within the internal project team.