Tech, Tool Room

About the role

The Tech, Tool Room is responsible for the development, manufacture, repair, maintenance and fixture fabrication. Applies skills and dexterity in the development of engineering prototypes, supports the improvement of products and processes and new product development, in keeping with SOPs and applicable regulatory guidance.

Duties and responsibilities

• Perform preventive and corrective maintenance to complex tooling/molds and related equipment, as required, including recording traceable information on device history records and may enter information into system (e.g., SAP, Maximo) as appropriate while applying knowledge of processes in the use of machines to ensure successful outcomes, as well as to device process changes.
• Set up, operate and program (Milling, Lathes, other) machines. To manufacture and/or modify more complex existing tooling, fixtures and/or metal assemblies as required.
• Design, fabricate, and improve jigs, fixtures, gauges, templates, work aids, and error-proofing devices that support manufacturing efficiency, quality, ergonomics, and safety.
• Provide technical guidance, mentoring, and skills training to Tool & Die personnel, machinists, technicians, and other manufacturing personnel.
• Evaluate tooling, molds, fixtures, and manufacturing processes to identify opportunities for improvement in quality, reliability, cycle time, cost reduction, and manufacturability
• Read, interpret, and work from engineering drawings, GD&T requirements, CAD models, assembly drawings, process specifications, and technical documentation.
• Ensure compliance with all applicable Quality System, Environmental Health & Safety (EHS), GMP, and regulatory requirements while maintaining a safe and organized work environment.
• Follow established Good Documentation Practices (GDP), change control procedures, and company policies while ensuring accurate record retention and traceability.

Minimum Requirement

• Associate's Degree or equivalent from a Technical Institute with certification in Tool & Die making, technical school certificate, vocational training, or engineering technology is strongly preferred.
• 7 Years of experience as a Tool & Die Maker or equivalent position in the plastic processing industry, preferably in a medical device environment, including the manufacture, modification of tooling/molds, fixtures and/or metal assemblies by making use of equipment such as manual and CNC bulk material removal machines (such as lathes, mills, grinders, drills, electric discharge machines) and welding equipment (micro-welding)