Equipment Engineer

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.