Research Engineer, Product Engineering

A*STAR RESEARCH ENTITIES; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

A leading research organization in Singapore is seeking an Engineer/Senior Engineer to develop innovative medical technology products. This role involves engineering novel devices, supporting clinical testing, and producing compliance documentation. Candidates should possess a degree in Engineering, at least 3 years of experience in medical device development, and skills in CAD software. Strong problem-solving abilities and collaboration skills are essential for success in this dynamic and impactful role.

Qualifications

• Minimum of 3 years experience in design and development of life science instruments or medical devices.
• Knowledge of FDA CFR 820 and ISO 13485 regulations.
• Experience with ISO 1491 for thermal management and mechanical noise/vibration control.

Responsibilities

• Develop and engineer novel medical technology products from concept to pilot production.
• Support clinical feasibility studies and prototype testing in hospital environments.
• Create ISO 13485 compliant technical documentation.

Skills

Problem-solving

Collaboration

Attention to detail

Technical documentation

Education

Degree in Engineering or science related fields

Tools

SolidWorks or alternative CAD program

MS Office

Job description

MedTech Catapult is a national initiative for accelerating the development of high‑value MedTech projects through an in‑house product engineering unit. This productization unit is responsible for supporting the development of technologies through the medical device development cycle to produce full‑fledged hardware product systems. The Engineer/Senior Engineer will report to the Lead, Engineer, Systems Engineering.

Job Responsibilities

• Develop and engineer novel medical technology products from concept to pilot production.
• Support early clinical feasibility studies and testing of functional prototype in hospital environment.
• Design, develop and test devices by building functional prototypes in a laboratory and test environment.
• Develop ISO 13485 compliant technical documentation for life science instrumentation.
• Support development of intellectual property portfolio in device design and process technology know‑how.
• Prepare and support product development and quality planning (project schedule, resources, budgets, etc.).
• Manage and assist with verification and validation activities and documentation.
• Collaborate with outside vendors on the design and sourcing of materials, components, and processing.
• Support and prepare documentation to support quality system for design functions (project plans, concept document, FMEA, design input, test results, drawings, etc.).
• Complete activities according to project phase checklists.
• Review document changes in manufacturing for impact on design intent.
• Interact closely with engineers from other disciplines to achieve an optimized design within the stipulated project schedule.
• Provision of technical input to help identify and mitigate project risks affecting project schedules and plans.
• To support other activities for product engineering when required.

Requirements

• Degree in Engineering or science related fields.
• At least 3 years of experience in design & development of life science instruments/medical devices (e.g. hardware, connected devices)
• Computer skills including MS Office, SolidWorks or alternative CAD program
• Prototyping and materials knowledge for medical devices
• Experience with FDA CFR 820 and ISO 13485 regulations
• Experience with engineering systems in accordance with ISO 1491 thermal management, mechanical noise/vibration control, electrical safety will be advantageous
• Experience in electro‑mechanical motion systems design and optics is a plus
• Experience in material selection and biocompatibility is a plus
• Strength in problem‑solving and decision‑making
• High energy level, attention to detail and a sense of urgency
• Good collaboration skills, organized and detailed with willingness to learn
• Demonstrate strong interpersonal skills.