Principal Systems Engineer

Innovation - Diversity - 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.           

Principal Systems Engineer   - Urology Products

Marlborough, MA   Hybrid (3+ days per week)

About the role:

As Principal Systems Engineer on Boston Scientific‘s Urology team, you will act as a technical leader, playing a critical role in development of medical device product systems from concept to product launch and acquisition and integration of active implantable product systems. The Systems Engineer considers both the business and the technical needs of all customers with the goal of providing a quality product that meets the user needs. You will work closely with cross-functional teams, balancing user needs, market opportunity, and business requirements.

The Principal Systems Engineer provides technical and engineering expertise including due diligence support, technology evaluations, gap assessments and remediation planning working closely with cross-functional teams. In this role, you will lead engineering efforts to develop quality, complex medical device systems (active implantable products, lasing systems) Electronic Medical Equipment (EME), combination medical devices, and/or software only products, etc., for market leading differentiation and segment growth on Urology franchises.

Your responsibilities will include:

• Work with all stakeholders to translate user needs into design requirements (e.g. hardware, software, mechanical, electrical, interface, etc.) consisting of system requirements, sub-system requirements, product/system security requirements, and system interface requirements to define the system as a whole and all associated sub-systems.
• Support system architecture, design and integration of new or next generation technologies/products (implantable & capital platform eco-systems) under BSC quality system in collaboration with technical/cross-functional stakeholders.
• Provide due diligence support through technology evaluations, assessments of the acquired product’s technical feasibility, quality, usability and compliance risks.
• Provide systems thinking perspective for system/sub-system definition and understand how product changes affect the larger system
• Identify technical risks, develop risk burndown plans, and implement phased system integration approaches, characterization studies to mitigate risk.
• Support special studies on subjects such as improving system quality, usability, system partitioning, trade off assessments etc. by researching and analyzing options for implementation.
• Analyze system requirements to determine testability, completeness and support system test development, systems characterization and build traceability.
• Contribute to system risk assessment activities, Use/Design FMEA’s activities.
• Support product/feature design, concept generation and functional prototyping for systems and associated interfaces.
• Act as an R&D representative on cross-functional deliverables.
• Create and support documentation as part of the Product Development Process (PDP) and Quality Management System.
• Drive mechanisms for detailed project planning, tracking, and issue identification.
• Collaborate with R&D, regulatory, quality, project management teams for integration activities and communicate findings/recommendations to senior leadership and key stakeholders
• Provide leadership role on championing functional best practices and problem solving across functions/divisions and disciplines via internal/external experts to resolve difficult challenges.
• Build Systems Engineering capability by mentoring engineers in engineering activities/methodologies and domain knowledge.
• Continuously improve processes and work methodologies (using agile/lean principles to eliminate waste) to help solve complex, interdisciplinary problems by interfacing with peers/cross-functional groups.

 Required qualifications:

• BS or above in Electrical Engineering, Computer Science, Biomedical Engineering or related field
• 8+ years of engineering experience with product development activities, preferably in a regulated environment. 
• Experience with requirements authoring, design, trade-off analysis, systems integration, risk management and V&V processes.
• Proficiency in technical documentation, risk assessment and design control processes.
• Knowledge of Software and System Architectures and design principles.
• Experience using configuration management, test management, requirements management, and issue tracking systems.
• Ability to lead teams through a structured approach to solving complex technical problems.
• Strong knowledge of Design Controls & Risk Management practices
• Willingness to work at our Marlborough, MA site (Hybrid 3+ days per week)

Preferred Qualifications & Experience 

• 5+ years of experience leading product development teams in a Medical Regulated Environment.
• Experience in building and modifying System Architectures, Systems Requirements, Systems Design for implantable medical devices and connected platform eco-systems.
• Knowledgeable in Human Factors and Usability Engineering processes as part of regulated product development.
• Demonstrated ability to interact with and influence key stakeholders both internal and external to the organization.
• Experience dealing with regulatory questions from FDA, BSI, TUV
• Strong personal credibility & excellent communication skills
• Ability to work cross-functionally and communicate technical insights effectively

Requisition ID: 602321 

Base Salary Range

Minimum Salary: $ 103700 

Maximum Salary: $ 197000 

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 exempt  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.

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.