Senior Engineer, Equipment Project

LINXENS SINGAPORE PTE. LTD.

Singapore, Singapore
Not specified
Equipment and process engineering in medical device industry
Process validation iq oq pq experience
Iso 13485 regulatory compliance knowledge
LINXENS SINGAPORE PTE. LTD. is seeking a Senior Engineer for Equipment Projects, focusing on project planning, equipment design, and validation in the medical device industry. The ideal candidate should have 6-10 years of relevant experience, strong communication skills, and a solid understanding of ISO 13485 standards

Job Summary

  • This role involves leading the design, development, and integration of equipment while ensuring compliance with ISO 13485 standards.
  • The successful candidate will manage the full project lifecycle from early planning through to industrialization and process validation.
  • Key responsibilities include conducting gap analyses, preparing business cases, and overseeing supplier selection for new equipment.

Matching Summary

Match Score: 85

LINXENS SINGAPORE PTE. LTD. is seeking a Senior Engineer for Equipment Projects, focusing on project planning, equipment design, and validation in the medical device industry. The ideal candidate should have 6-10 years of relevant experience, strong communication skills, and a solid understanding of ISO 13485 standards.

Skills & Requirements

Must-have

  • Equipment and Process Engineering in medical device industry
  • Process validation IQ OQ PQ experience
  • ISO 13485 regulatory compliance knowledge
  • Equipment sourcing qualification and commissioning
  • Project planning and timeline definition skills

Nice-to-have

  • Excellent communication and stakeholder management
  • Experience with emerging technology monitoring
  • Prototyping capabilities development expertise

Key Requirements

  • Bachelor's degree in Mechanical or Industrial Engineering
  • 6-10 years of experience in Equipment and Process Engineering
  • Medical device industry background required
  • Knowledge of IQ, OQ, PQ validation processes

Work Rights

Not specified

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