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Manufacturing Engineer, Medical (Manual Equipment)

Keywords / Skills : Manufacturing Engineer, Medical (Manual Equipment)

5 - 10 years
Posted: 2019-01-12

Manufacturing/ Engineering/ R&D
Other Manufacturing/ Engineering/ R&D
Posted On
12th Jan 2019
Job Ref code
Job Description
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

  • 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.

  • 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).

About Company

EA Registration No. 12C5526

Founded in 1950, and established in Asia in 2004, VOLT is a NYSE listed Fortune 1000 provider of talent (recruitment), technology and consulting services with 4,200 full time employees, some 30,200 contractors and 192 offices across Europe, North and South America and Asia.

Volt's workforce solutions include executive search, contract and temporary staffing, managed services programs, vendor management systems and recruitment process outsourcing. Volt combines consultative focus, Six Sigma practices and efficient e-procurement technologies to deliver the talent and processes that help our customers succeed.
We connect companies with industry-leading specialists. Our proven search process cultivates a superior network of active and passive professionals, enabling us to provide best-fit experts in a broad range of business disciplines.

Our areas of expertise include Accountancy & Finance, Engineering, Human Resources, Information Technology & Telecommunications, Life Sciences, Procurement & Supply Chain, Property, and Sales & Marketing.

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