Lead Engineer, Mechanical (MedTech Catapult)

Agency for Science, Technology and Research (A*STAR); Singapore; On-site; SGD 80,000 - 130,000; Full time

Job summary

An innovative agency is looking for a Lead Engineer in Mechanical Engineering to spearhead the development of advanced medical technology products. The successful candidate will have a strong background in life science instruments, with at least 8-10 years of experience. Responsibilities include product design, prototype testing, and collaboration with external vendors to ensure quality and compliance with medical standards.

Qualifications

• At least 8-10 years of experience in design & development of life science instruments or medical devices.
• Experience with FDA CFR 820 and ISO 13485 regulations is essential.
• Prototyping knowledge for medical devices is required.

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

Problem-solving

Collaboration skills

Attention to detail

Leadership

Education

MSc in Mechanical Engineering

Tools

SolidWorks

MS Office

Job description

Lead Engineer, Mechanical, MedTech Catapult

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 Lead Engineer will report to the Lead, Product Engineering.

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.

· Acquisition, set up, and, installation qualification of new equipment, including the creation of PM procedure as necessary.

· Prepare and support product development and quality planning (project schedule, resources, budgets, etc.).

· Develop feasibility and reliability testing plans, including the development and validation of accurate in-vitro and in-vivo models and methods.

· Focus 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 as 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 solve project risks affecting project schedules and plans.

· To support other activities for product engineering when required.

Requirements

· MSc in Mechanical engineering or related fields.

· At least 8-10 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

· Experience in interventional medical device development is highly desirable

· 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