12 month DA - Stryker Anngrove
What you will do:
Support AO project teams with 3D print machine build support and relevant post-production requirements. Co-ordinate builds and relevant post-production requirements in parallel with Operations support and report to AO project teams and relevant AO Technicians.
Perform all necessary laboratory and Product Development testing and supply data required for FDA submissions. Equipment will include metallographic, optical microscopy, chemical and physical analysis, dimensional measurement, First Article Inspection etc. of metals, polymers etc. as required.
Support DOEs, capability studies, MSAs, Technical support e.g. workmanship standards, product quality issue resolution, quality control support, engineering support.
Work closely with the Quality Department to ensure all documentation associated with validation and new product introduction in a regulated environment is accurate, executed in the correct sequence and completed in a timely manner.
Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches.
Provide training for manufacturing team members.
Ensure adherence to GMP and safety procedures.
All other duties as assigned.
What you will need:
Holds (or is undertaking) cert/diploma/trade in related discipline or has minimum of 2 years additive manufacturing production experience in a regulated environment.
Experience in the medical device industry is an advantage.
Computer literacy.
Demonstrated Mechanical/Technical Aptitude.
Strong communication skills.
Ability to work on own initiative as part of a team in a fast paced, results oriented environment.
Proven problem solving skills and hands on approach.
Experience of working in regulated GMP based machine floor environment required.
Capable of working as part of a multi-disciplined team.