Lead Engineer, Mechanical

2 weeks ago


Singapore A*STAR - Agency for Science, Technology and Research Full time

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.
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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