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