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
