Engineer/Senior Engineer, Mechanical

3 weeks ago

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

Overview

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

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.
  • Provide technical input to help identify and mitigate project risks affecting project schedules and plans.
  • 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.
Seniority level
  • Associate
Employment type
  • Full-time
Job function
  • Engineering and Information Technology
Industries
  • Research Services

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