Location:
Draper, UT (Onsite)
Schedule:
Standard
Duration:
1 year Contract (W2)
Pay Rate:$22.50 – $26.50/hr
Position Summary
Our client is a medical device manufacturer with clean room production operations. This is a hands-on maintenance and repair role responsible for keeping manufacturing equipment running reliably, alongside setting up and executing feasibility studies, experiments, and tests — both creating and following established protocols — to validate and improve equipment and manufacturing processes/methods based on engineering principles. Equipment supported includes maintenance systems, laser cutters, furnaces, chemical polishing equipment, and heat treatment via salt bath. This role analyzes results, makes recommendations, and develops reports for Engineering review, and operates a variety of test equipment to assess characteristics of the manufacturing environment.
Essential Functions and Responsibilities
- Maintain and repair manufacturing equipment, including laser cutters, furnaces, chemical polishing equipment, and salt bath heat treatment systems, to minimize downtime and ensure consistent operation.
- 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.
- Perform IQ (Installation Qualification) validation testing to support equipment recovery and requalification.
- Follow required documentation and SOPs to recover equipment following maintenance, repair, or downtime events.
- 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.
Education/Experience
- H.S. Diploma or equivalent
- 2-4 years of experience required
- Medical device background ideal; open to candidates from other industries with a strong mechanical/mechanic background
- Relevant previous job titles may include: Maintenance Technician, Process Technician, or candidates with military technical experience
Knowledge/Skills
- IQ validation experience, with the ability to support testing
- Working knowledge of electrical AC systems
- Basic robotics knowledge
- Strong mechanical aptitude
- Solid safety background
- Familiarity with SOPs and required documentation to recover equipment, ideally in a medical device environment
- 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 and adherence to the client's Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
- 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
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