- 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.
- 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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Validation Engineer - Irvine, United States - Ascendum KPS
Description
Job description
Education (Required):
Bachelor's Degree in Engineering or Scientific field Required
Preferred Skills:
