Manufacturing Engineer – Medical Devices

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

Our client is a leading local medical device contract manufacturer supporting the development and manufacturing of medical devices for global markets.
Working Days: Monday – Friday
Working Hours: 8:00am – 5:30pm
Location: East area

Job Responsibilities

• Provide Design for Manufacturability (DFM) and Design for Assembly (DFA) input during product design reviews and prototype development.
• Evaluate product designs for manufacturability, assembly feasibility, reliability and cost effectiveness.
• Support design transfer activities from R&D to manufacturing for new products.
• Develop manufacturing processes, workflows and detailed work instructions for new products.
• Develop and validate manufacturing processes using IQ/OQ/PQ methodologies.
• Design, build and qualify manufacturing fixtures, jigs, tools and test equipment.
• Develop and validate custom equipment, fixtures and manufacturing processes to support production.
• Define equipment specifications and support procurement, installation and commissioning of manufacturing equipment.
• Develop and validate critical manufacturing tests to ensure product quality and performance.
• Support product and process continuous improvement initiatives, including troubleshooting and root cause investigations.
• Participate in design and process risk management activities, including dFMEA and pFMEA.
• Prepare and maintain process documentation including FMEAs, control plans, work instructions and validation reports.
• Support regulatory documentation and maintain audit‑ready records.
• Collaborate with R&D, Quality, Regulatory, Supply Chain and Operations teams on product and process development.
• Provide technical guidance and training to operators, technicians and junior engineers.
• Ensure manufacturing processes comply with applicable quality management and medical device regulatory requirements.
• Perform other duties as assigned.

Requirements

• Bachelor's Degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Mechatronics or a related discipline.
• 3–5 years of experience as a Manufacturing Engineer, Process Engineer or Advanced Manufacturing Engineer supporting product development.
• Good understanding of FDA 21 CFR 820, ISO 13485 and ISO 14971.
• Experience in product/device continuous development and transfer; NPI experience will be an advantage.
• Hands‑on experience with CAD software such as SolidWorks will be an advantage.
• Experience with process validation, equipment qualification and manufacturing documentation.
• Knowledge of Lean, Six Sigma or continuous improvement methodologies will be an advantage.
• Experience with statistical analysis tools such as Minitab or JMP will be an advantage.

We regret that only shortlisted candidates will be notified.