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Staff Advanced Manufacturing Engineer

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Katalyst Healthcares & Life Sciences

2021-12-03 08:52:12

Job location Covington, Georgia, United States

Job type: fulltime

Job industry: Consulting & Corporate Strategy

Job description

Job Description

Responsibilities:

  • Provide technical leadership in the concept development of design control documentation
  • Develop and drive the technical project plans and schedules
  • Lead technical process reviews
  • Assess design for manufacturability plans Lead site selection activities
  • Conceptualization and development of all methods and processes
  • Coordination of all development and manufacturing of new tooling and equipment
  • Coordination and support of all new vendor tooling and molds
  • Development and release of all product and process documentation
  • Planning, ordering and management of component inventory
  • Performing process characterization of all new operations and processes.
  • Developing, executing, analyzing and writing reports for validation protocols
  • Developing new product cost estimates
  • Preparation of capital equipment requisitions (CB2)
  • Evaluation and recommendation of new materials
  • Development and management of a process development plan
  • Documentation including PFMEA specifications, methods and labor standards review
  • Component inventory transition plan
  • Facility selection, coordination & preparation
  • Equipment moves and installation
  • IQ, OQ, PQ protocol development and execution
  • Validation and training support
Requirements:
  • BS degree in Engineering (mechanical, chemical, biomedical or similar) or equivalent required
  • Eight (8) years' experience or MS degree with six (6) years' experience preferred
  • Demonstrated proficiency with mold tooling and design, machinery, assembly fixtures, equipment and tooling procurement and design
  • High level of written and verbal communication skills
  • Ability to conceptualize ideas, motivate and focus individuals and teams and drive projects through completion on time and on budget
  • Ability to travel as required
  • Understanding and ability to execute DOEs, process validations and process characterizations
  • Understanding of GMPs and medical device regulations as they apply to manufacturing

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