Lead Systems Architect
2 weeks ago
Core Values: Innovation - Diversity - Collaboration - Excellence
At Boston Scientific, we empower our employees to leverage their full potential by collaborating with a diverse and high-performing workforce, addressing significant challenges in the healthcare sector. With access to cutting-edge tools, resources, and training, we support your professional growth and career aspirations.
Role Summary:
We are looking for a seasoned Lead Systems Architect to become a vital member of the Boston Scientific Neuromodulation Research and Development team. In this influential role, you will be instrumental in the creation of neuromodulation systems and platforms, guiding them from initial concept through to market introduction. The Systems Architect will address both the technical and business requirements of our customers, ensuring the delivery of high-quality products that fulfill user expectations. You will collaborate closely with multidisciplinary teams, aligning user requirements, market potential, and business objectives. Your leadership will be crucial in engineering sophisticated medical device systems, including implantable devices, Electronic Medical Equipment (EME), combination medical devices, and software-only solutions, aimed at achieving market differentiation and growth in pain management and neurological sectors.
Key Responsibilities:
- Engage with stakeholders to convert user needs into comprehensive design specifications (hardware, software, mechanical, electrical, interface, etc.), encompassing system requirements, sub-system requirements, product/system security requirements, and system interface requirements.
- Contribute to the architecture and design of innovative technologies/products (implantable and connected platform ecosystems) in partnership with technical and cross-functional teams.
- Translate overarching customer, business, and manufacturing requirements into detailed technical specifications.
- Ensure the effective development and support of hardware, mechanical, electrode/lead, and software systems along with their interfaces.
- Serve as an R&D representative on cross-functional projects.
- Identify technical risks, formulate risk mitigation strategies, and implement phased system integration approaches.
- Conduct special studies to enhance system quality, usability, and conduct trade-off assessments by evaluating implementation options.
- Analyze system requirements for testability and completeness, supporting system testing, characterization, and traceability.
- Participate in system risk assessment activities and contribute to Use/Design FMEA processes.
- Generate and maintain documentation as part of the Product Development Process (PDP) and Quality Management System.
- Lead detailed project planning, tracking, and issue resolution efforts.
- Champion functional best practices and problem-solving across various functions and disciplines by collaborating with internal and external experts.
- Enhance Systems Engineering capabilities by mentoring engineers in methodologies and domain knowledge.
- Continuously refine processes and methodologies (utilizing agile/lean principles) to tackle complex interdisciplinary challenges through collaboration with peers and cross-functional teams.
- Assist Regulatory Affairs with product submissions.
- Bachelor's or Master's degree in Electrical Engineering, Computer Science, Biomedical Engineering, or a related discipline.
- Over 10 years of experience in product development, preferably within a regulated environment.
- Proficient in requirements authoring, systems design, trade-off analysis, and verification.
- Familiarity with Software and System Architectures and design principles.
- Experience with configuration management, test management, requirements management, and issue tracking systems.
- Ability to guide teams through structured problem-solving approaches for complex technical challenges.
- Strong understanding of Design Controls and Risk Management practices.
- Excellent communication skills and personal credibility.
Preferred Qualifications:
- At least 5 years of experience leading product development teams in a regulated medical environment.
- Experience in developing and modifying System Architectures, Systems Requirements, and Systems Design for implantable medical devices and connected platform ecosystems.
- Knowledge of Human Factors and Usability Engineering processes in regulated product development.
- Proven ability to engage and influence key stakeholders both internally and externally.
- Experience addressing regulatory inquiries from FDA, BSI, TUV.
Compensation: The anticipated annual base salary for this full-time position will range from $100,700 to $191,300, along with an annual bonus target (subject to eligibility and other requirements) and the value of core and optional employee benefits offered at Boston Scientific.
Boston Scientific is committed to fostering a diverse and inclusive workplace, recognizing that it enhances our innovation and effectiveness in advancing science for life and improving patient health. We advocate for inclusion, equality, and opportunity for all, creating a rewarding environment for our employees that reflects the diversity of the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.
Boston Scientific maintains a drug-free workplace. Candidates will be subject to a drug test as a pre-employment requirement for safety-sensitive positions.
As a leader in medical science for over 40 years, we are dedicated to addressing the most pressing challenges, united by a profound commitment to human life. Our mission to advance science for life focuses on transforming lives through innovative medical solutions that enhance patient outcomes, create value for our customers, and support our employees and communities.
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