Lead Engineer, Mechanical (MedTech Catapult)
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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.
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
Seniority level
Seniority level Mid-Senior level
Employment type
Employment type Full-time
Job function
Job function Engineering and Information Technology
Industries Research Services
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