Production Engineer

22 hours ago

Billerica, United States Whitridge Associates Full time

Essential Responsibilities:

  • Production Support: Collaborate with production operators and R&D engineers to identify and prioritize process improvement initiatives aimed at enhancing yield, reducing costs, and maximizing ROI. Lead the implementation of these improvements on the production floor.
  • Fixture and Equipment Design: Design or source new fixtures and equipment as needed, including overseeing documentation, qualification, validation, and maintenance processes.
  • Process Documentation: Develop and maintain comprehensive process documentation, including assembly and test procedures, equipment and component specifications, BOMs, process flows, and FMEAs.
  • Failure Investigation: Participate in the investigation of failures and develop actionable plans for corrective actions in response to audits and findings. Address work-in-progress (WIP) and incoming Material Review Board (MRB) issues promptly.
  • Supplier Coordination: Manage fabrication and procurement activities with external suppliers to ensure timely delivery of materials and equipment.
  • Regulatory Compliance: Support and uphold company objectives, policies, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), as well as FDA Quality System Regulations (QSR) and ISO standards. Knowledge of FDA QSR and ISO regulations is essential.
  • Cross-Functional Collaboration: Work effectively within a cross-functional team in a startup environment. Strong communication skills are required to convey technical updates and issues, with a preference for collaborative efforts over individual contributions.
  • Project Reporting: Provide regular updates on project status and schedule, utilizing key project metrics in presentations, action items, and meeting minutes for program and operations management.
  • Documentation Maintenance: Ensure accurate documentation of concepts, designs, and processes, while keeping abreast of advancements in medical, technical, and biomedical fields relevant to products.
  • Product Development Collaboration: Partner with product development teams to ensure that products are designed with manufacturability, testing, and inspection considerations in mind.

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