Principal Systems Engineer - Urology R&D

Additional Location(s): US-MA-Marlborough; US-MN-Arden Hills

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s 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, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.  

About the role:
Boston Scientific’s Urology team is looking for an experienced Principal Systems Engineer to help shape the future of complex medical device systems. This is a high-impact individual contributor role where you’ll lead systems engineering efforts across both capital equipment and active implantable devices, from early concept through product launch.

You’ll be instrumental in supporting the acquisition and integration of active implantable systems, bringing your engineering expertise to technology evaluations and cross-functional planning. Your work will help ensure that technical solutions align with user needs, market opportunities, and business goals.

In this role, you’ll collaborate with teams across disciplines to turn business and technical requirements into smart, effective solutions. You’ll also drive systems engineering activities across a diverse portfolio, including active implantables, capital systems, combination devices, and software-only products, fueling innovation and growth within the Urology franchise.

Work mode:
At Boston Scientific, we prioritize collaboration and synergy. This role follows a hybrid work model, requiring employees to be present at one of the designated office locations listed in the job posting, three days a week.

Your responsibilities will include:

• Support acquisition and integration efforts for complex active implantable product systems, including due diligence activities such as technology evaluations, gap assessments, and remediation planning in collaboration with cross-functional teams
• Define and modify system requirements and designs to enable seamless integration of acquired product systems
• Translate user needs into system-level design requirements for new product development, including hardware, software, mechanical, electrical, and cloud components
• Develop comprehensive system and sub-system requirements, including security and interface specifications, to define the overall system architecture
• Architect and integrate new or next-generation technologies and products (implantable and capital platform ecosystems) in compliance with BSC quality systems, in partnership with technical and cross-functional stakeholders
• Apply systems thinking to define system and sub-system interactions and assess how product changes impact the broader system
• Identify and mitigate technical risks through risk burndown planning, phased integration strategies, and characterization studies
• Conduct special studies focused on improving system quality, usability, partitioning, and design trade-offs by researching and analyzing implementation options
• Analyze system requirements for testability and completeness, and support the development of system tests, characterization, test methods, and traceability documentation
• Contribute to system-level risk management activities, including Use and Design Failure Modes and Effects Analyses (FMEA)
• Design product features, generate concepts, and create functional prototypes for systems and related interfaces
• Represent R&D on cross-functional teams to support product development deliverables
• Create and maintain documentation aligned with the Product Development Process (PDP) and Quality Management System requirements
• Drive detailed project planning, progress tracking, and issue identification across engineering activities
• Collaborate with R&D, regulatory, quality, and project management teams on integration activities and communicate findings and recommendations to senior leadership and stakeholders
• Champion functional best practices and cross-functional problem-solving by engaging with internal and external experts to address complex challenges
• Mentor engineers to build systems engineering capabilities across engineering methodologies and domain-specific knowledge areas
• Improve cross-functional processes and methodologies using agile and lean principles to address complex, interdisciplinary challenges

Required qualifications:

• Bachelor's degree in electrical engineering, computer science, biomedical engineering, or a related discipline
• Minimum of eight years of experience in product development activities, preferably within a regulated environment
• Experience in authoring requirements, system design, trade-off analysis, systems integration, risk management, and verification and validation (V&V) processes
• Proficiency in creating technical documentation and performing risk assessments and design control activities
• Understanding of software and system architectures, including associated design principles
• Experience working with configuration management, test management, requirements management, and issue tracking tools
• Demonstrated ability to lead teams using a structured, methodical approach to solving complex technical challenges
• Comprehensive knowledge of design controls and risk management practices
• Strong communication skills with the ability to build credibility across technical and non-technical audiences
• Proven ability to collaborate across functions and effectively communicate technical concepts and insights

Preferred qualifications:

• Master’s degree in electrical engineering, computer science, biomedical engineering, or a related discipline
• A minimum of five years of experience leading product development teams within a regulated medical environment
• Experience developing and modifying system architectures, system requirements, and system design for implantable medical devices and connected platform ecosystems
• Familiarity with human factors and usability engineering processes in compliance with regulated product development standards
• Proven ability to effectively collaborate with and influence internal and external stakeholders across various functional areas
• Experience supporting regulatory interactions with organizations such as the U.S. Food and Drug Administration (FDA), British Standards Institution (BSI), and TÜV

Requisition ID: 611375 

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 www.bscbenefitsconnect.com--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 non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

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).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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) isn’t just business, it’s personal. 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!

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 Company’s 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.  

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