Manufacturing Engineer - Medical Devices

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

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.