Senior R&D Engineer, Design Quality Assurance

Location: Singapore
Job Type: Permanent
Specialisation: Engineering & Manufacturing
Salary: S$5500 - S$7500 per month
Reference: BBBH9167_1623405882
Contact: Abhik Damani
Email: email Abhik

My client is a global name in the medical device sector and is recruiting for an R&D Quality/Design Assurance Engineer to support new product development and product maintenance.

  • Global Name
  • Innovative Products
  • Attractive Remuneration

Responsibilities:

  • Ensure that all design control and production / process control projects meet applicable regulatory and corporate standards.
  • Handle projects and tasks from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards
  • Develop quality plans, execute inspection & testing activities and work with Manufacturing on the transfer of quality requirements.
  • Develops and review product verifications and validation test plans.
  • Review product reliability specifications and conduct risk management activities including failure mode effects analysis (FMEA), hazard analysis, fault tree analysis (FTA) etc.
  • Participate in product or process design and change activities, including design reviews.
  • Apply Design to Cost and Design for Manufacturability methods to support leaders in achievement of project objectives.
  • Ensure proper design and development documentation as per ISO 13485/FDA Standards.
  • Create and implement changes to ensure strict compliance with FDA Standards.
  • Ensure a safe, healthy, and environmentally friendly workplace by observing procedures and ISO 14001 regulations.

Requirements:

  • Advanced Degree in Biomedical, Electrical, Mechanical, Polymer, Sciences or equivalent
  • 5-7 years' work experience in a Product Development/Design Assurance/R&D Quality function in the medical device/biotech sector
  • Experience in the design and development of products in accordance with ISO 13485.
  • In depth know-how and experience of quality techniques: DFSS, DoE, FMEA, etc.
  • Knowledge in manual assembly processes, involving silicone and molded/extruded parts.
  • Experience in the entire Design life cycle and Phase-Gate development process.
  • Experience with SAP/MES Systems will be a plus.

Please send your resume in WORD format by clicking the apply button below or contact Abhik Damani on +65 6701 1527 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1544061 (Abhik Damani).