Sr Production Engineer

Found in: Appcast Linkedin GBL C2 - 2 weeks ago


Burlington, United States Whitridge Associates Full time

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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