
Lead Engineer, Mechanical
2 weeks ago
Lead Engineer, Mechanical (MedTech Catapult)
Join to apply for the Lead Engineer, Mechanical (MedTech Catapult) role at A*STAR - Agency for Science, Technology and Research
Lead Engineer, Mechanical (MedTech Catapult)
4 days ago Be among the first 25 applicants
Join to apply for the Lead Engineer, Mechanical (MedTech Catapult) role at A*STAR - Agency for Science, Technology and Research
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.
- 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
Seniority level
Seniority level
Mid-Senior level
Employment type
Employment type
Full-time
Job function
Job function
Engineering and Information TechnologyIndustries
Research Services
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