Validation Engineer

4 weeks ago

Irvine, United States Ascendum KPS Full time

Job description

  • Improving manufacturing processes using engineering methods (e.g., LEAN methods, basic statistics) for continuous process improvement.
  • Developing basic experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyzing results, making recommendations, and developing reports.
  • Analyzing and resolving basic 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 customers expectations, using project management tools (e.g., Project Plan, Risk Analysis).
  • Identifying opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes.
  • Overseeing manufacturing support tasks; giving instruction to technicians on conducting tests; training technicians and providing feedback; and coordinating technician work.
  • Mainly will inspect, measure, analyze, audit, calibrate and test the instrumentation, equipment, machines and procedures.

Education (Required):

Bachelor's Degree in Engineering or Scientific field Required

Preferred Skills:

  • Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)
  • Basic documentation, communication (e.g., written and verbal) and interpersonal relationship skills
  • Basic understanding of statistical techniques
  • Previous experience working with lab/industrial equipment preferred (if applicable)
  • Good understanding and knowledge of principles, theories, and concepts relevant to Engineering
  • Good problem-solving, organizational, analytical and critical thinking skills
  • Good understanding of processes and equipment used in assigned work
  • Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
  • Strict attention to detail
  • Ability to interact professionally with all organizational levels
  • Ability to manage competing priorities in a fast-paced environment
  • Must be able to work in a team environment, including immediate supervisor and other team members in the section or group; and may interact with vendors
  • Ability to build stable working relationships internally

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