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Open nowPosted 23 days ago

Manufacturing Engineer

MyCareersFuture94,028 open roles

Pay
SGD 3,500 – SGD 5,000 a month
Where
East, Singapore
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Your applicationOpen nowManufacturing EngineerMyCareersFuture · East, Singapore

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The clock on this job

Early applications get read.

7.8% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
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  2. 3.4%3 days
  3. 7.8%7 days
  4. 14.3%14 days
  5. 33.7%30 days
This job: posted 23 days ago

The posting

  • Provide Design for Manufacturability (DFM) & Design for Assembly (DFA) input to R+D teams during design reviews, and prototype iterations to optimize manufacturability, reliability, and cost.
  • Participate in design risk management activities including dfMEA and pfMEA to identify and mitigate manufacturing-related risks.
  • Evaluate design concepts for manufacturability, assembly feasibility, and cost-effectiveness.
  • Support design transfer activities from R+D to manufacturing for new products.
  • Develop and execute project plans for technology transfer, including timelines, equipment needs, and resource requirements.
  • Create manufacturing workflow processes and detailed work instructions for new product.
  • Develop and validate manufacturing processes (IQ/OQ/PQ) for new product lines.
  • Design, build, and qualify custom equipment, fixtures, jigs, and manufacturing processes for prototype.
  • Develop and validate custom equipment, fixtures, jigs, and manufacturing processes.
  • Specify, document, procure, qualify, implement, and improve fixtures, hand tools, an equipment used in manufacturing.
  • Design and build prototypes, fixtures, tools, and test systems that support product development and manufacturing.
  • Determine, incorporate, and validate critical tests used in manufacturing to ensure product quality and performance.
  • Develop test methods, simulation models, and reliability strategies to reduce design and manufacturing risk.
  • Author and maintain design documentation for a regulatory controlled environment including process FMEAs, control plans, work instructions, and validation reports.
  • Contribute to documentation for regulatory submissions (510(k), CE Mark Technical File) and maintain audit-ready records.
  • Collaborate with R+D teams (mechanical, electrical, systems) to characterize new hardware designs and emerging technologies.
  • Work with Quality, Regulatory, Supply Chain, and Operations teams to ensure compliance with medical device standards (ISO 13485, ISO 14971, FDA 21 CFR 820).
  • Define equipment specifications, lead procurement, installation, and commissioning of manufacturing equipment.
  • Ensure all manufacturing process development activities comply with FDA 21CFR 820, ISO 13485 design controls and production controls, and global regulatory standards.
  • Perform all work in compliance with the company Quality Management System (QMS), including creation, review, and maintenance of required documentation.
  • Provide technical guidance and training to operators and technicians on manufacturing processes and best practices.
  • Follow Design Control for medical devices to ensure compliance to company’s Quality Management System and ISO 13485.
  • Perform other ad-hoc duties as assigned by immediate supervisor.

Education

  • Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Mechatronics, or related field.

Experience

  • 3–5 years of experience as a manufacturing engineer, process engineer, or advanced manufacturing engineer supporting product development with significant mechanical/electromechanical content.
  • Direct experience with surgical, endoscopic, urological, or minimally invasive devices is highly desirable.

Skills

  • Understanding of FDA 21 CFR 820, ISO 13485 design controls and production controls, and risk management (ISO 14971).
  • Hands-on experience with manufacturing process development, test fixture design, CAD tools (e.g., SolidWorks), and electro-mechanical assembly processes.
  • Proficiency in statistical analysis tools (e.g., Minitab, JMP) for process capability analysis, DOE, and validation data interpretation.
  • Experience with Lean, Six Sigma, and continuous improvement methodologies.
  • Hands-on experience with FDA 510(k), EU MDR, and global regulatory pathways for Class II/III devices.
  • Understanding of design transfer, process validation, and manufacturing expectations in regulatory filings.
  • Excellent written and verbal communication for protocol authoring, report writing, and cross-functional collaboration.
  • Problem-solving mindset with ability to drive root-cause investigations and process improvements.
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