MedTech Manufacturing Engineer (DFM/ DFA Expert)

RECRUITPEDIA PTE. LTD.; Singapore; On-site; SGD 60,000 - 100,000; Full time

Job summary

RECRUITPEDIA PTE. LTD. is recruiting a Manufacturing Engineer to support product development and transfer to manufacturing. The role focuses on DFM/DFA input during reviews and prototype development, evaluating manufacturability, and ensuring cost-effective processes.

You will develop and validate manufacturing processes (IQ/OQ/PQ), create fixtures and tooling, and contribute to risk management and regulatory-ready documentation in a fast-paced medical device environment.

Qualifications

• Bachelor's degree in a relevant engineering field.
• 3–5 years in manufacturing/process engineering or advanced manufacturing engineering.
• Experience with FDA 21 CFR 820, ISO 13485 and ISO 14971 is preferred.
• NPI experience and product development transfer experience is good to have.
• Proficiency with CAD software (SolidWorks) and process validation.
• Knowledge of lean, six sigma, or continuous improvement methodologies.
• Experience with statistical tools such as Minitab or JMP.

Responsibilities

• Provide DFM and DFA input during product design reviews and prototype development.
• Evaluate designs for manufacturability, assembly feasibility, reliability and cost.
• Support design transfer activities from R&D to manufacturing for new products.
• Develop manufacturing processes, workflows and work instructions for new products.
• Develop and validate manufacturing processes using IQ/OQ/PQ methodologies.
• Design, build and qualify fixtures, jigs, tools and test equipment.
• Define equipment specs and support procurement, installation and commissioning.
• Develop and validate critical manufacturing tests to ensure product quality and performance.
• Support product/process continuous improvement and root cause investigations.
• Participate in design and process risk management (dfMEA, pfMEA).
• Prepare and maintain process documentation (FMEAs, control plans, work instructions).
• Support regulatory documentation and audit-ready records.
• Collaborate with R&D, Quality, Regulatory, Supply Chain and Operations teams.

Skills

DFM

DFA

Process optimization

Lean Six Sigma

Statistical analysis

Education

Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Mechatronics or related discipline

Tools

SolidWorks

Minitab

JMP

Job description

RECRUITPEDIA PTE. LTD. is recruiting a Manufacturing Engineer to support product development and transfer to manufacturing. The role focuses on DFM/DFA input during reviews and prototype development, evaluating manufacturability, and ensuring cost-effective processes.

You will develop and validate manufacturing processes (IQ/OQ/PQ), create fixtures and tooling, and contribute to risk management and regulatory-ready documentation in a fast-paced medical device environment.