Senior Embedded Software Engineer

Participate in technology evaluations, technical specification development, technical assessments and validation of firmware architectures, embedded software, and system integration aspects of active implantable medical devices. Support the firmware specification development, firmware architecture, embedded firmware development, and integration for active implantable medical devices. Ensure that firmware development aligns with IEC 62304, FDA, ISO 13485, ISO 14971and other regulatory standards governing medical device firmware. Participate in Identifying potential risks, cybersecurity vulnerabilities, and integration challenges in acquired technologies. Ensure acquired firmware meets medical device cybersecurity and safety standards, including FDA premarket cybersecurity guidance, IEC 62443. Collaborate with cross-functional teams, including hardware engineers, systems engineers, risk management, regulatory affairs, and clinical teams, to ensure seamless device integration. Maintain thorough design documentation, traceability matrices, and software development lifecycle (SDLC) artifacts for regulatory submissions. Participate in software and system risk management activities throughout the SDLC. Participate in testing strategies (Unit / Integration) and design verification protocols to verify firmware functionality. Provide technical inputs on low-power embedded systems, wireless communication (e.g., BLE, NFC, RF telemetry), and real-time operating systems (RTOS). Establish and document firmware development lifecycle (SDLC) artifacts and processes to align with internal quality management systems (QMS). Perform firmware testing, debugging, and verification efforts using tools such as unit testing frameworks, hardware-in-the-loop (HIL) simulations, and automated test environments. Collaborate with regulatory teams on 510(k), PMA, or CE Mark submissions involving firmware-related changes. Contributes to the process of transferring the product from development to manufacturing. Foster a culture of innovation, continuous improvement, and knowledge sharing within the R&D team. Bachelor's degree or higher in Computer Science, Computer Engineering, Software Engineering, Electrical Engineering, or related major 4+ years of experience in embedded firmware development 2+ years in implantable or Class III medical devices. Expertise in low-power embedded systems, programming for systems with or without real-time operating systems (RTOS), and microcontroller-based firmware development. Experience in firmware risk assessment, cybersecurity, and regulatory compliance for implantable devices. Experience using oscilloscopes, logic analyzers, and other related tools. Detail-oriented and well organized. Experience in integrating BLE embedded systems with iOS, Android and Windows applications. Knowledge of PC application development in Microsoft Visual Studio (e.g. C#.Net). Hands-on experience with oscilloscopes, logic analyzers and other related tools. Willingness to work onsite at our Irvine, CA site Experience with mergers & acquisitions (M&A) due diligence in the medical device sector. Hands-on experience with secure bootloaders, cryptographic protocols, and over-the-air firmware updates for implantable devices. Expertise in BLE (Bluetooth Low Energy) in embedded systems including peripheral, central, dual roles, pairing, GATT profiles, security, custom services. Low level understanding of BLE software stacks (e.g. those from On Semi, Nordic) and experience in optimizing BLE software stack for performance constraints and ultra-low-power consumption constraints. Requisition ID : 606223 Base Salary Range Minimum Salary : $ 86600 Maximum Salary : $ 164500 Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above. Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements). As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you! That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and / or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.