• 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.
