Responsibilities

• Think deeply about the system level behaviour of the arrangement of components and the behaviours they fulfill, considering requirements that may be missing, use cases, edge cases and abuse cases.

• System Integration & Testing: Perform the integration and validation of mechanical systems within the product, ensuring that all subsystems work together to meet performance and safety requirements.

• Testing Under Real-World Conditions: Design and implement system-level tests for the product, simulating both standard and extreme conditions (e.g., vibration, water ingress, temperature fluctuations) to ensure reliability and robustness.

• Cross-Functional Collaboration: Work closely with the electrical, software, and mechanical engineering teams to ensure seamless system-level performance, and to continuously refine their component solutions. Your ability to bridge gaps and translate technical concepts between these disciplines using analogies where relevant, will be crucial.

• Risk Analysis: Be familiar with risk analysis techniques to identify patient risk, technical risk, and project risk, and translating this to a risk driven integration + testing approach. Ensure compliance with medical device standards (e.g. ISO 13485). Facilitate documentation for regulatory approvals.

• Test Fixtures & Automation: Design test fixtures, with an emphasis on identifying and pushing for 'bang for buck' level of automation (pure automation may have negligible gains if the final 10% of set up is quick). In summary, the built tests will minimise the set up time for future repeat regression testing triggered by a product design iteration.

• Flexible: Keen to grow into multiple skill areas, and not afraid to get hands dirty. For example, if some electronics or software is required to measure, perturb or otherwise automate test conditions, getting stuck into learning it (if unfamiliar).

  
  

Requirements

• Bachelor’s or Master’s degree in Mechanical Engineering, Systems Engineering, or a related field.

• 5+ years experience in systems engineering/mechanical engineering. Preferred to have experience in medical device industry or other highly regulated industries.

• Experience in designing and implementing rigorous test plans for system and subsystem validation, bonus for devices subjected to harsh real-world conditions.

• Proficiency in conducting risk analyses (FMEA, Hazard Analysis) and integrating relevant outcomes into system design and testing strategies.

• Solid foundation in mechanical engineering with broad knowledge of systems, electronic and software engineering principles.

• Expertise in CAD software (e.g., SolidWorks) and experience with simulation tools (e.g., ANSYS) to support both design and validation efforts.

• Hands-On Development: Ability to dive into areas beyond mechanical engineering, such as electronics or software, when necessary to enhance system performance or testing.

• Demonstrated ability to lead, take initiative, and drive projects forward independently, particularly as the first hire in a growing team.

  
  

Preferred

• Experience with creating and maintaining detailed documentation required for regulatory submissions and compliance for medical devices. Strong understanding of medical device regulations, including ISO 13485.

• Familiarity with embedded systems, firmware, back end structures, cloud integration and test automation techniques.

• Experience in developing and executing V&V plans for medical devices.