Medical Device Manufacturing Engineer - DFM & Process Validation

RECRUITPEDIA PTE. LTD.; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

RECRUITPEDIA PTE. LTD. is recruiting for a Manufacturing Engineer to support the design-to-manufacturing transition of medical devices in Singapore. The role focuses on DFM/DFA input during design reviews and prototype development, ensuring manufacturability and cost efficiency.

You will develop manufacturing processes, validate with IQ/OQ/PQ, and create fixtures and test equipment. Collaboration with R&D, Quality, Regulatory, and Operations is essential.

Qualifications

• Bachelor's degree in a relevant engineering discipline.
• 3–5 years in manufacturing/process/advanced manufacturing engineering.
• Knowledge of FDA 21 CFR 820, ISO 13485 and ISO 14971.

Responsibilities

• Provide DFM and DFA input during design reviews and prototypes.
• Evaluate manufacturability, assembly feasibility, reliability and cost.
• Support design transfer from R&D to manufacturing for new products.
• Develop and validate manufacturing processes, workflows, and work instructions.
• Create and validate critical processes using IQ/OQ/PQ methodologies.
• Design, build, and qualify fixtures, jigs, tools, and test equipment.
• Support regulatory documentation and maintain audit-ready records.
• Collaborate with R&D, Quality, Regulatory, Supply Chain and Operations teams.

Skills

DFM

DFA

Design transfer

Statistical analysis

Lean Six Sigma

CAD (SolidWorks)

Education

Bachelor's degree in Mechanical/Manufacturing/Biomedical/Mechatronics

Tools

SolidWorks

Minitab

JMP

Job description

RECRUITPEDIA PTE. LTD. is recruiting for a Manufacturing Engineer to support the design-to-manufacturing transition of medical devices in Singapore. The role focuses on DFM/DFA input during design reviews and prototype development, ensuring manufacturability and cost efficiency.

You will develop manufacturing processes, validate with IQ/OQ/PQ, and create fixtures and test equipment. Collaboration with R&D, Quality, Regulatory, and Operations is essential.