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Manufacturing Engineer, Medical (Manual Equipment)

SGD4000 to SGD5000 per month

My client is a world leader in the medical device space and now seek an experienced Manufacturing Engineer who will be responsible for the support of Manufacturing Operations, maintaining or improving the specified operational standards. This person needs to be an expert on manually using equipment

Responsibilities:

  • Qualifies/Validates product/process according to schedule and follow up production until pass off requirement met.
  • Assume responsibility as the subject matter expert of the assigned manufacturing process owner and ensure the sustainability of the processes for manufacturing operation
  • Define and control production process including tooling and equipment. Validate design specifications and shop floor application of new product, tools, or equipment
  • Provide technical leadership and support to process downtime and equipment repair and analyze and report impact assessment as required for assigned equipment and processes
  • Provide adequate tooling and equipment to ease device manufacturability.
  • Initiate, evaluate, approve and implement Engineering Change Order (ECR/ECO)
  • Lead in development, training, qualification and validation activities for product or technology transfers.
  • Execute CAPA and NC tasks and ensure timely response to audit findings
  • Ensures compliance with company policies, programs, procedures, regarding to government and regulatory agencies regulations (e.g. ISO, FDA, OSHA)
  • Works with the Manufacturing and Supply Chain teams to apply principles, concepts and tools for capacity projects and Lean Sigma initiatives.

Requirements:

  • Degree in Engineering or related discipline with relevant work experience with at least 5 years’ experience in Manufacturing Environment from a regulated industry (GMP)
  • Prior experience with manual use of equipment
  • Experience in Lean Sigma Methodology and Continuous Improvements Programs.
  • Effective communication skills to deal with Team Members and Supervisors
  • Technical knowledge and experience in CAPA, SPC, Minitab, yield improvement
  • Experience with Process Validation and IQ/OQ/PQ
  • Good written reporting skills

Please send your resume in WORD format by clicking the apply button below or contact Abhik Damani on +65 6701 1527 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1544061 (Abhik Damani).

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  • Singapore
  • Permanent
  • Fri Jan 11 07:29:08 2019
  • BBBH6175