Project Engineer (Medical Device)

DART SOLUTIONS PTE. LTD.

Singapore
Manage project schedules for medical devices
Ensure iso 13485 and fda compliance
Lead iq/oq/pq validation activities
The role involves managing the end-to-end medical device project lifecycle from concept through mass production

Job Summary

  • The role involves managing the end-to-end medical device project lifecycle from concept through mass production.
  • Candidates will ensure strict compliance with regulatory standards including ISO 13485 and FDA 21 CFR Part 820.
  • The position offers structured career development within a growing engineering organization focused on quality-driven manufacturing.

Matching Summary

Match Score: 85

The role involves managing the end-to-end medical device project lifecycle from concept through mass production.

Skills & Requirements

Must-have

  • Manage project schedules for medical devices
  • Ensure ISO 13485 and FDA compliance
  • Lead IQ/OQ/PQ validation activities
  • Develop engineering documentation and procedures
  • Coordinate cross-functional manufacturing teams

Nice-to-have

  • Strong stakeholder management skills
  • Detail-oriented problem-solving abilities
  • Experience in fast-paced manufacturing
  • Ability to translate customer requirements

Key Requirements

  • Bachelor's Degree or Diploma in Engineering
  • Minimum 2 years of project engineering experience
  • Strong understanding of medical device regulations

Work Rights

Not specified

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