Principal Software Engineer
Principal Software Engineer
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Job Description
Innovation - Diversity - Caring - Global Collaboration - Winning Spirit- High Performance
At Boston Scientific well give you the opportunity to harness all thats within you by working in teams of diverse and high-performing employees tackling some of the most important health industry challenges. With access to the latest tools information and training well help you in advancing your skills and career. Here youll be supported in progressing whatever your ambitions.
Principal Software Engineer - Boston Scientific Urology Products
Location: Irvine CA Hybrid 3 days per week
About the Role:
We are seeking an experienced and highly skilled Principal Software Engineer to join Boston Scientific Urology team. In this role you will be part of evaluation integration of software and firmware technologies for medical devices for Axonics/Boston Scientific Urology products. As a technical leader and hands-on contributor you will lead integration activities and support software development ensuring compliance with medical device regulations. This role requires experience with application software development embedded systems android platform test frameworks and regulatory-compliant medical device software development processes.
Key Responsibilities
- Participate in technology evaluations technical assessments and validation of software architectures embedded software and system integration aspects of acquired implantable medical devices.
- Support software architecture development testing strategies and risk management activities for software applications
- Evaluate compliance and ensure software/firmware development aligns with IEC 62304 FDA ISO 13485 ISO 14971and other regulatory standards governing medical devices.
- Oversee testing strategies (Unit/Integration) and design verification protocols to verify software/firmware functionality post-acquisition.
- Support software/ firmware testing debugging and verification efforts using tools such as unit testing frameworks hardware-in-the-loop (HIL) simulations and automated test environments.
- Identify potential risks cybersecurity vulnerabilities and integration challenges in acquired technologies. Ensure acquired software meets medical device cybersecurity and safety standards including FDA premarket cybersecurity guidance IEC 62443.
- Collaborate with cross-functional teams including hardware engineers systems engineers quality regulatory affairs manufacturing and PMO to ensure seamless device integration.
- Establish and document software development lifecycle (SDLC) artifacts and processes to align with internal quality management systems (QMS). Maintain thorough design documentation traceability matrices and SDLC artifacts for regulatory submissions.
- Provide technical inputs on low-power embedded systems wireless communication (e.g. BLE NFC RF telemetry) and real-time operating systems (RTOS).
- Act as a technical mentor for software engineers guiding best practices during integration and new product software/firmware development
- Collaborate with regulatory teams on 510(k) PMA or CE Mark submissions involving firmware-related changes.
- Foster a culture of innovation continuous improvement and knowledge sharing within the R&D team.
Required Experience
- B.S or higher in Computer Science Electrical Engineering Computer Engineering Software Engineering or related major.
- 5 years of experience in software development . (Masters degree may substitute for one year of experience)
- 3 years in embedded or application software for medical devices
- Sound knowledge of software engineering principles and practices.
- Knowledge of programming languages such as Swift Java Dart or Objective-C and mobile operating systems and platforms such as iOS and Android.
- Experience in developing mobile applications in an FDA regulated environment or other regulated industry.
- Knowledge and use of OOP design principles API design principles.
- Knowledge in low-power embedded systems real-time operating systems (RTOS) and microcontroller-based firmware development.
- Strong project management and communication skills.
- Ability to work at our Irvine CA site
Preferred qualifications:
- Experience with mergers & acquisitions (M&A) due diligence in the medical device sector.
- Experience in risk assessment cybersecurity and regulatory compliance for implantable devices. Knowledge of ISO 13485 and FDA QSR is desired.
- Experience using oscilloscopes logic analyzers and other related tools.
- Strong C/C skills for programming microcontroller systems.
- Detailed knowledge of BLE stacks and BLE API on mobile platforms
- 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 secure bootloaders cryptographic protocols and over-the-air firmware updates for implantable devices.
Requisition ID:605544
Base Salary Range
Minimum Salary:$99100
Maximum Salary: $188300
The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) see --will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. 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 rolesmay 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.
So choosing a career with Boston Scientific (NYSE: BSX) isnt just business its personal. And if youre 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!
At Boston Scientific we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. 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.
Boston Scientific Corporation has been and will continue to be an equal opportunity employer. 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. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company you will be expected to meet the ongoing requirements for your roles including any new requirements should the Companys policies or protocols change with regard to COVID-19 vaccination.
Among other requirements Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. 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.
Required Experience:
Staff IC
Employment Type
Full Time
