Product Engineer

MERIT MEDICAL SINGAPORE PTE. LTD.

Yishun, Singapore
**
Bio-medical mechanical or electrical engineering degree
3 years product or process engineering experience
Medical device industry background required
** Merit Medical Singapore Pte. Ltd. is seeking a Product Engineer to oversee design change controls and product sustaining engineering for critical care products. The ideal candidate will possess a degree in engineering, experience in the medical device industry, and strong project management and technical skills. **

Job Summary

  • The incumbent will be responsible for design change controls and product sustaining engineering initiatives for critical care products.
  • The role requires validating product designs per customer requirements while ensuring compliance with domestic and international regulatory standards.
  • The engineer must maintain design history files, perform failure mode effect analysis, and resolve product design issues using technical problem-solving capabilities.

Matching Summary

Match Score: 75

** Merit Medical Singapore Pte. Ltd. is seeking a Product Engineer to oversee design change controls and product sustaining engineering for critical care products. The ideal candidate will possess a degree in engineering, experience in the medical device industry, and strong project management and technical skills. **

Skills & Requirements

Must-have

  • Bio-Medical Mechanical or Electrical Engineering degree
  • 3 years product or process engineering experience
  • Medical device industry background required
  • CAD Design and SolidWorks proficiency
  • Statistical methods knowledge

Nice-to-have

  • Thermoplastic material design experience
  • U.S FDA regulations knowledge
  • ISO 13485 Quality System Standard familiarity
  • ISO 14971 Risk Management expertise
  • European Medical Devices Regulation knowledge

Key Requirements

  • Degree in Bio-Medical / Mechanical / Electrical Engineering
  • Minimum 3 years' experience in medical device company
  • Knowledge of U.S FDA regulations (advantage)
  • Familiarity with ISO 13485 and ISO 14971 (advantage)

Work Rights

Not specified

Tailored Resume

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