Engineer/Senior Engineer, Mechanical (MedTech Catapult)

A*STAR RESEARCH ENTITIES; Pasir Panjang; On-site; MYR 60,000 - 80,000; Full time

Job summary

A leading research organization in Malaysia seeks an Engineer/Senior Engineer to develop innovative medical technology products from concept to pilot production. This role requires a degree in Mechanical Engineering, at least 3 years of relevant experience, and proficiency with SolidWorks. The ideal candidate will have strong problem-solving skills and experience with FDA regulations. Competitive salary and benefits are offered.

Qualifications

• At least 3 years of experience in design & development of life science instruments/medical devices.
• Experience with FDA CFR 820 and ISO 13485 regulations.
• Experience in electro-mechanical motion systems design is a plus.

Responsibilities

• Develop and engineer novel medical technology products from concept to pilot production.
• Design, develop and test devices by building functional prototypes.
• Manage and assist with verification and validation activities.

Skills

Design & development of life science instruments

Prototyping knowledge

Problem-solving skills

Collaboration skills

Education

Degree in Mechanical Engineering or related fields

Tools

SolidWorks

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, Product Engineering.

Industry

Medical Devices, Life Science Instrumentation, Hardware Product Systems

Job Responsibilities

• Develop and engineer novel medical technology products from concept to pilot production.
• Production of high-quality engineering drawings and assembly specifications.
• Design, develop and test devices by building functional prototypes in a laboratory and test environment.
• 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.).
• Work on design for manufacturing by designing and developing pilot manufacturing equipment and procedures whilst assessing feasibility of processes and support manufacturing with validation plans and time studies.
• Manage and assist with verification and validation activities and documentation
• Collaborate with outside vendors on the design and sourcing of materials, components, and processing.
• 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 Mechanical Engineering or 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 in electro-mechanical motion systems design, and fluidics 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
• Demonstrate strong interpersonal skills and leadership skills

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.