Manufacturing Process Engineer

Manufacturing Process Engineer

Pay Rate: $45 to $49/HR

Duration:
12 months

Location:

Draper, UT (Onsite)

Our Client is a Global medical device Manufacturer.

We are looking for a Manufacturing Process Engineer.

• Optimizing manufacturing processes, including using engineering methods (e.g.,
  SIX Sigma and LEAN methods) for continuous process improvement and/or re-design/design of equipment,
  tools
  , fixtures
  , etc. to improve manufacturing processes, employing technical design skills.
• Writing and executing protocols to qualify and validate manufacturing processes; analyzing results, making recommendations, and developing reports
• Analyzing and resolving moderately complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).
• Developing training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
• Establishing project plans to ensure deliverables are completed to the customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).
• Overseeing manufacturing support tasks; giving instructions to technicians on conducting tests; training technicians and providing feedback; and coordinating technicians
• Collaborating across sites and cross-functional teams (R&D and commercial).
• Coordinating manufacturing builds and raw material allocations.
• Leading process validations (IQ, OQ, PQ).
• Supporting documentation for the team

• A Bachelor's degree in Engineering or a scientific field with 2-5 years of previously related industry experience, or a Master’s degree in Engineering or a scientific field with 1-3 years of previously related experience, is required.
• Medical device industry experience
• Manufacturing process creation and process improvement
• Experience with process validations (IQ, OQ, PQ).
• CAD experience (Solid Works or Creo preferred) and tools/fixtures design
• Understanding of the Phase-gate product development
• Strong documentation
  , communication (e.g., written and verbal), and interpersonal relationship skills, including consultative and relationship management skills
• Understanding of design requirements documentation,
  risk management plans, inspection criteria,
  test method development
  , and validation activities
• Knowledge of process and design transfer activities
• Understanding/knowledge of Design for Manufacturing (DFM) principles
• Proven expertise in usage of MS Office Suite, including MS Project
• Basic understanding of statistical techniques
• Ability to drive tasks with minimal supervision; self-starter
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Good leadership skills and the ability to influence change
• Knowledge of and adherence to Environmental Health and Safety and Quality guidelines as they relate to the department's clean room medical device manufacturing
• Knowledge of applicable FDA regulations for the medical device industry