Senior Development Engineer

3 days ago

Kampung Bukit Minyak, Penang, Malaysia Intersurgical Medical Sdn Bhd Full time 120,000 - 240,000 per year
Job Description:

As a Senior Development Engineer, you will be responsible for driving development of new products, engineering change, testing and validation, risk management and handover of projects into production.

Qualifications & experience:
  • Education or Competency Requirement: Bachelor's degree in an engineering discipline or equivalent. Preferably specialises in Mechanical Engineering, Materials Engineering or Polymer Engineering.
  • Experience: A minimum of six (6) years of relevant experience covering research and development and new product introduction, ideally within the medical device manufacturing environment.
  • Strong knowledge on design controls, product and development specifically related to plastic parts, process knowledge on injection moulding, extrusion or assembly processes, drawings and 3D modelling (SolidWorks), risk management and validation.
  • Proficiency in tolerance stack up analysis or mould design would be added advantage.
Key Responsibilities:
  • Lead the research, design and development of new products.
  • Train and guide junior engineers and technicians in design and development related topics.
  • Carry out material selection, prototyping or feasibility studies.
  • Source, select and develop suppliers to support design and development work.
  • Generate and maintain product and design documentation such as product specifications, 2D drawings and 3D models, tolerance stack up analysis, Bill of Materials and more.
  • Participate in mould design for manufacturability review, mould trials and qualification activities.
  • Drive test development, design verification activities and stability studies.
  • Support validation activities.
  • Perform failure analysis and risk management activities.
  • Identify and drive continuous improvement and engineering change efforts.
  • Create and maintain design history file and device master record.
Additional Requirements:
  • Detail oriented, analytical, critical and have strong problem-solving skills.
  • Excellent communication and team collaboration abilities.
  • Preferably have ISO 13485 and FDA 21 CFR 820 training or exposure.
  • Work location: Bukit Minyak and Batu Kawan, Penang.
Benefits:
  • Competitive salary package
  • Annual performance and salary review
  • Enjoy a familial company atmosphere
  • Group insurance plan and medical expense claim

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