Sr Production Engineer

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.
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