Role & responsibilities Develop and execute comprehensive software V&V strategies, plans, and schedules for medical device software. Lead a team of engineers in performing software verification and validation activities. Ensure compliance with international standards (e.g., IEC 62304, ISO 14971) and regulatory requirements (e.g., FDA, MDR). Define software test requirements, test cases, and test protocols based on functional and design specifications. Perform hands-on testing, including manual and automated testing, to ensure product quality and performance. Analyse test results, identify defects, and collaborate with development teams to resolve issues. Author and maintain detailed V&V documentation, including test plans, test reports, and traceability matrices. Ensure software meets safety, usability, and cybersecurity standards. Support regulatory submissions by providing required V&V artifacts. Work closely with cross-functional teams, including software development, quality assurance, risk management, and regulatory affairs. Provide mentorship and training to junior engineers to build expertise in V&V practices. Preferred candidate profile Perks and benefits
Role & responsibilities Lead end-to-end mechanical design of electro mechanical medical device components and sub-assemblies from concept through production release. Develop detailed 3D CAD models and 2D drawings using SolidWorks, including complex surface modelling for ergonomic and aesthetic design features. Apply Geometric Dimensioning & Tolerancing (GD&T) principles to ensure design intent, fit, and manufacturability. Perform tolerance analysis and mechanical calculations to validate design robustness. Select materials and manufacturing processes (injection moulding, machining, casting, sheet metal, etc.) suitable for medical applications. Support engineering builds and hands-on mechanical testing to evaluate design functionality, performance, and reliability. Participate in design brainstorming, feasibility studies, and FMEA sessions to identify and mitigate risks early in the design cycle. Collaborate closely with suppliers, toolmakers, and contract manufacturers to ensure design feasibility, cost-effectiveness, and manufacturability. Review supplier drawings, tooling concepts, and first article inspection (FAI) reports. Drive Design for Manufacturability (DFM) and Design for Assembly (DFA) improvements throughout the development process. Generate and maintain engineering documentation, including BOMs, drawings, ECOs, and test reports, in compliance with ISO 13485 and FDA 21 CFR Part 820 design control requirements.
Role & responsibilities Lead the hardware design and development of embedded medical devices from concept to commercial release. Own the system architecture, component selection, schematic design, PCB layout guidance, and hardware validation. Develop analog and digital circuitry, including sensor interfaces, signal conditioning, ADC/DAC, and power management. Design and integrate microcontroller-based systems, ensuring efficient hardwarefirmware interaction. Implement and test communication interfaces such as UART, SPI, IC, CAN, USB, BLE, or Ethernet. Conduct hardware bring-up, debugging, and optimization using oscilloscopes, logic analyzers, and other lab tools. Perform detailed testing and analysis of individual modules and subsystems within the device to ensure performance, signal integrity, electrical safety, and compliance with design specifications. Execute verification and validation testing, including functional, environmental, and EMC evaluations. Analyze test data, identify root causes of design or performance issues, and implement corrective actions. Work closely with firmware and mechanical teams to ensure seamless system integration. Ensure hardware compliance with medical safety and EMC standards (IEC 60601-1, IEC 60601-1-2) and other relevant regulatory requirements. Prepare and review design documentation, including design history files (DHF), risk assessments, test reports, and verification protocols. Support prototype development, design verification, validation testing, and transition to manufacturing. Preferred candidate profile