jobs in A*STAR - Agency For Science, Technology And Research

全职 Senior Engineer, Mechanical, MedTech Catapult 工作, 薪水, A*STAR - Agency For Science, Technology And Research 公司招聘中 - Ricebowl

Senior Engineer, Mechanical, MedTech Catapult

A*STAR - Agency For Science, Technology And Research

Undisclosed

全职

Singapore

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工作地点

  • Singapore

职位描述

岗位职责

Job Responsibilities

  • Develop and engineer novel medical technology products from concept to pilot production.
  • Design, develop and test devices by building functional prototypes in a laboratory and test environment.
  • Production of high-quality engineering drawings and assembly specifications.
  • Develop feasibility and reliability testing plans, including the development and validation of accurate in-vitro and in-vivo models and methods.
  • Plan and perform verification and validation (V&V) activities and documentation to ensure compliance with requirements.
  • 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.
  • Collaborate with outside vendors on the design and sourcing of materials, components, and processing.
  • Prepare documentation to support quality system for design functions (concept document, risk analysis including FMEA, design input, design output, 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.
  • Provision of technical input to help identify and mitigate project risks affecting project schedules and plans.
  • To support other activities for product engineering when required.

Requirements

  • Bachelor’s or Master’s degree in Mechanical Engineering or related fields.
  • Minimum 5 years of experience in the design and development of medical devices/life science instrumentation.
  • Proficiency in computer applications, including MS office, SolidWorks or alternative CAD software.
  • Prototyping and materials knowledge for medical devices
  • Experience with FDA 21 CFR Part 820 and ISO 13485 quality management and regulatory requirements.
  • Experience in the design of electromechanical motion systems, fluidics and optics is a plus
  • Experience in thermal management simulation and electromagnetic enclosure shielding design is a plus.
  • Experience in material selection and biocompatibility is a plus
  • Strength in problem-solving and decision-making
  • Highly motivated, attention to details and a sense of urgency
  • Highly organized, proactive, and effective in collaborating across cross-functional teams.
  • Demonstrate strong interpersonal skills and leadership skills

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