The Senior Electromechanical Engineer, Medical Devices will work with our cross-functional Systems Engineering teams to develop FDA-regulated medical devices that delivers diagnostic results that are clear and actionable. You will be counted on to contribute to realizing a product that is intuitive, reliable, and secure. The primary responsibilities include the conceptualization, design, and testing of electromechanical equipment and systems. This role involves collaboration with other engineers and professionals to create system specifications and detailed technical designs.
Responsibilities:
• Understanding the system. You must analyse mechanical, electronic, and software components and how they interact within an existing medical device to investigate function and performance problems encountered in the field, lab, quality control, and during manufacturing. If necessary, conduct forensic analysis to identify the root causes of problems by reviewing technical documents (drawings, schematics, code), examining parts (measuring, scoping), performing experiments, and analysing recorded data.
• Solving problems. Demonstrate the capability to work autonomously on complex issues methodically, taking responsibility for the correctness of the solution. Evaluate different solutions for the same problem, such as whether to alter software, manufacturing processes, or hardware components. Consider the effectiveness and scalability of the approach and trade-offs between short- and long-term impacts. Anticipate potential system failures by understanding design implications.
• Improving design and process. Work with Contract Manufacturing Organisations (CMOs) to implement changes in manufacturing. This includes addressing component obsolescence, filling specification gaps, enhancing quality control, or design changes to improve reliability or robustness. Ensure changes are executed diligently with attention to detail to prevent the introduction of new issues to a device already in serial production.
• Documenting and communicating work. Document technical decisions, changes, and their rationale. Present and review these with internal teams and external partners. Adapt to communicate clearly with different audiences: engineers, technicians, scientists, operations staff, and sales personnel. Maintain comprehensive project and technical documentation including plans, requirements and reports.
• Support the R&D work of our science team. Assist scientists in conducting their research by developing and improving equipment.
Education, Experience and Demonstrated Skills:
• MSc/MEng in engineering (e.g. Systems, Biomedical, Mechatronics, Electronics) or related discipline.
• 5+ years’ experience in a regulated industry where Quality Systems are essential, e.g. ISO 13485.
• Experience using CAD software (e.g. SolidWorks or Altium) for electromechanical designs towards manufacture.
• Strong analytical and problem-solving skills, with a hands-on approach to troubleshooting and repair of instrumentation within labs.
• Capable of managing multiple projects simultaneously with minimal supervision.
• Excellent verbal and written communication, and teamwork skills.
• Experience writing embedded software, preferably C, where the code has been successfully released for use on operational devices is desirable.
• Experience designing products is desirable.
• Experience using various sensors, motors, pneumatics, data-logging, and circuit components is desirable.
• Experience collaborating or coordinating with external technical teams is desirable.
• Experience in electrochemistry or voltammetry, particularly device design is desirable.