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Equipment Engineer

2 months ago

burlington, United States Whitridge Associates Full time

• Identify process improvement opportunities to existing manual operations and manage the design, development, implementation, validation and maintenance of automated or semi-automated manufacturing fixtures, tooling and systems. Areas of focus include component mating and curing, measurement and vision systems, and functional test systems.

• Work with engineers, machinists, designers and Quality Assurance to create detailed electromechanical drawings for new products, product revisions, components, assemblies or tools, typically using CAD technology to create drawings

• Qualify and/or Validate fixtures, tooling and systems via IQ/OQ/PQ, Gage R&R and Process Capability Studies.

• Coordinate fabrication and purchasing activities with outside suppliers

• Ability to work in cross-functional teams in a startup environment. Highly effective communicator of technical status and issues required. Must enjoy team approach over individual contributions.

• 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.

• 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.