Responsibilities
- Engage in assessing emerging technologies and defining technical requirements for firmware and embedded software used in implantable medical devices.
- Support the development of firmware architecture, detailed design, and real-time embedded systems in compliance with IEC 62304 and FDA guidelines.
- Ensure adherence to quality and safety standards including ISO 13485, ISO 14971, FDA QSR, and cybersecurity standards such as FDA premarket guidance and I combustion 62443.
- Detect and address risks related to firmware, cybersecurity weaknesses, and integration issues, especially with externally acquired technologies.
- Work closely with hardware, systems, risk, regulatory, and clinical teams to ensure cohesive device development and implementation.
- Create and maintain thorough design records, traceability documentation, and software lifecycle deliverables to support regulatory submissions like 510(k), PMA, and CE Mark.
- Participate in risk assessment and management activities across the product development lifecycle.
- Design and implement unit and integration testing strategies and assist in verification processes.
- Lead technical efforts in low-power embedded systems, wireless protocols such as BLE, NFC, and RF telemetry, and real-time operating system integration.
- Conduct firmware testing, troubleshooting, and validation using test equipment like oscilloscopes, logic analyzers, hardware-in-the-loop setups, and automated testing platforms.
- Develop and refine firmware development processes in alignment with the organization's quality management system.
- Assist in transitioning products from research and development to manufacturing and ongoing engineering support.
- Promote innovation, process improvement, and knowledge exchange within the R&D engineering group.
Work Arrangement
Hybrid
Other
- Employment visa sponsorship is not offered for this role currently.
- Relocation assistance is not provided for this position at this time.
- This position is classified as safety-sensitive, requiring a prohibited substance test as part of the hiring process.
- Some U.S.-based roles may require proof of COVID-19 vaccination; applicants will be informed during the interview process if this applies.
- In Massachusetts, it is illegal to require or administer a lie detector test for employment purposes.
Not available at this time
