Principal Systems Engineer

Additional Location(s):  N/A

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:

We are seeking an experienced Principal Systems Engineer to join the Boston Scientific Neuromodulation R&D team. As a technical contributor and leader, you will play a critical role in developing neuromodulation systems and platform from concept to product launch. 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. In this role, you will lead engineering efforts to develop quality, complex medical device systems such as implantable products, Electronic Medical Equipment (EME), combination medical devices, and/or software only products, etc., for market leading differentiation and segment growth on pain and brain 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 and design of new or next generation technologies/products (implantable & connected platform eco-systems) in collaboration with technical and cross-functional core teams and stakeholders.
• Translate high-level customer, business & manufacturing needs into technical requirements.
• Ensure effective development and support of hardware, mechanical, electrode/lead and software systems and associated interfaces.
• Act as an R&D representative on cross-functional deliverables.
• Identify technical risks, develop risk burndown plans, and implement phased system integration approaches 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.
• Analyzes 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.
• 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.
• Provides leadership role on championing functional best practices and problem solving across functions/divisions and disciplines via internal/external experts to resolve difficult challenges.
• Builds 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.
• Assists Regulatory with product submissions.

Required qualifications:

• BS or MS in electrical engineering, Computer Science, Biomedical Engineering or related field
• 10+ years of experience with product development activities, preferred in a regulated environment. 
• Experience with requirements authoring, systems design, trade-off analysis and verification.
• 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
• Strong personal credibility & excellent communication skills

Preferred qualifications:

• At least 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 Engine