RD Technician

Responsibilities:

Consult with Engineers, Technicians, and Assemblers on processes to execute experiments and/or production runs. Support related to equipment investigations, testing, objective evidence of product dispositions and rework support work necessary.

Review documentation and take appropriate actions to ensure that information is appropriately catalogued and follow through to validation and qualification of equipment, including transferring information to appropriate locations, e.g., ECRs, SOPs, drawings, and tooling, for Engineering approval.

Utilize manufacturing software (e.g., JDE, QMS,PLM) to update documentation in systems.

Follow through with development of training and documentation materials, based on collaboration with Engineering, including identifying opportunities for modification and making recommendations, enabling the seamless knowledge transfer of project and manufacturing processes; applying knowledge of processes to devise process changes in collaboration with Engineering.

May lead projects related to new equipment validation, equipment investigations, testing, objective evidence of product dispositions and rework.

Identify potential improvement opportunities and propose solutions to optimize process and/or equipment, e.g., re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, for Engineering review.

Provide coaching and guidance to technicians

Additional Skills:

Excellent computer skills required, including experience with MS Office Suite; ERP/MRP systems experience preferred

Ability to read, comprehend, write and speak English, and good communication skills required

Knowledge of Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing and FDA regulations

Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment

Strict attention to detail

Ability to provide feedback in a professional, direct, and tactful manner

Must be able to work in a team environment and with minimum supervision

Proven success adhering to project schedules and managing small projects

Substantial knowledge of validation and improvement of automated equipment

Ability to troubleshoot manufacturing equipment

Knowledge of material compatibility in the proposed use environment

Education and Experience:

H.S. Diploma or equivalent

8-10+ years of experience required

Experience in a regulated industry such as Medical Device or Pharma required

FT, on-site, M-F, contract