Manufacturing Engineer, Medical Devices - NPI & Validation

Beecruit Pte Ltd; Singapore; On-site; SGD 56,000 - 61,000; Full time

Job summary

Beecruit Pte Ltd is seeking a Manufacturing Engineer to support the development and industrialisation of new medical devices. This role sits at the intersection of R&D and Manufacturing, guiding products from design through process development and transfer into production.

You will collaborate with R&D, Quality, Regulatory, Supply Chain and Operations to ensure manufacturability, reliability and compliance with medical-device requirements.

Qualifications

• Bachelor's degree in Mechanical, Manufacturing, Biomedical, Mechatronics Engineering or related discipline.
• Around 3–5 years of Manufacturing, Process or Advanced Manufacturing Engineering experience.
• Experience supporting product development involving significant mechanical/electromechanical content.
• Hands-on exposure to process development, process validation and design transfer.
• Experience with CAD/SolidWorks, test fixtures and electromechanical assembly.

Responsibilities

• Provide DFM and DFA input during product design reviews and prototype development.
• Support design transfer and NPI from R&D into manufacturing.
• Develop manufacturing processes, workflows and detailed work instructions for new products.
• Develop and execute IQ/OQ/PQ and process validation activities.
• Participate in DFMEA/PFMEA, risk assessment and manufacturing risk mitigation.
• Design, build and qualify fixtures, jigs, tooling and custom manufacturing equipment.
• Evaluate manufacturing feasibility, assembly methods, cost and process capability.
• Develop manufacturing test methods and reliability strategies.
• Prepare and maintain controlled documentation including PFMEA, control plans, validation reports and work instructions.
• Support equipment specification, procurement, installation and commissioning.
• Drive root-cause investigations and continuous process improvements.
• Work within ISO 13485, ISO 14971 and FDA 21 CFR 820 requirements.

Skills

3–5 years experience

Process development

Design transfer

Root-cause investigations

Continuous improvement

Education

Bachelor's degree in Mechanical, Manufacturing, Biomedical, Mechatronics Engineering

Tools

CAD/SolidWorks

Test fixtures

Electromechanical assembly

Job description

Beecruit Pte Ltd is seeking a Manufacturing Engineer to support the development and industrialisation of new medical devices. This role sits at the intersection of R&D and Manufacturing, guiding products from design through process development and transfer into production.

You will collaborate with R&D, Quality, Regulatory, Supply Chain and Operations to ensure manufacturability, reliability and compliance with medical-device requirements.