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Process Engineer

  • Full Time, onsite
  • Pentamaster Corporation Berhad (Official)
  • Simpang Ampat, Malaysia
Salary undisclosed

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We're looking for Medical Device - NPI Engineer / Process Engineer

As an NPI Engineer in our medical devices manufacturing team, you will be responsible for leading the development and implementation of new product introductions. You will collaborate cross-functionally to ensure that products meet regulatory standards, quality expectations, and market requirements. Your expertise will play a vital role in transitioning products from development to production efficiently and effectively.

Key Responsibilities:

  • Lead and manage the new product introduction process from concept to commercialization.
  • Collaborate with R&D, Quality Assurance, Regulatory Affairs, and Manufacturing teams to define product specifications and requirements.
  • Develop and maintain project plans, timelines, and budgets for NPI projects.
  • Conduct risk assessments and implement strategies to mitigate potential issues during product development and production.
  • Ensure compliance with FDA regulations, ISO standards, and other applicable guidelines.
  • Coordinate and execute validation and verification activities for new products, including design verification and process validation.
  • Analyze and interpret data related to product performance, quality, and reliability.
  • Provide technical support and training to production teams during the ramp-up phase.
  • Facilitate communication between stakeholders, ensuring alignment on project goals and progress.
  • Continuously seek process improvements and efficiencies within the NPI framework.

Qualifications:

  • Bachelor’s degree in Engineering (Biomedical, Mechanical, Electrical, or related field) or equivalent experience.
  • [3-5+] years of experience in NPI, product development, or manufacturing engineering within the medical device industry.
  • Strong understanding of regulatory requirements (CE, FDA, ISO 13485) and quality systems in the medical device sector.
  • Proficiency in project management tools and methodologies.
  • Excellent problem-solving, analytical, and communication skills.
  • Experience with design control processes and product lifecycle management.
  • Ability to work collaboratively in a team environment and manage multiple projects simultaneously
  • Experience with Lean Manufacturing and Six Sigma methodologies.
  • Familiarity with CAD software and product design tools.
  • Previous experience in a GMP environment.