Boston Scientific Principal Software Systems Design Engineer 

United States, California, Santa Clarita 

514652950

About the role:

The Principal Software Systems Design Engineer, for the Boston Scientific Neuromodulation R&D team, will be a technical contributor and leader, who 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), 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. software, mobile platforms, hardware, interface, etc.) consisting of system requirements, sub-system requirements, cybersecurity 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/cloud platform eco-systems) in collaboration with technical and cross-functional core teams and stakeholders.
• Translate high-level customer, business & manufacturing needs into technical requirements.
• Support product/feature design, concept generation and functional prototyping for 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 above from an accredited school in Electrical Engineering, Computer Science, Biomedical Engineering or related field
• 8+ years of experience with product development activities (experience in a regulated environment preferred).
• 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 Device Regulated Environment.
• Experience in building and modifying System Architectures, Systems Requirements, Systems Design for implantable medical devices and connected platform/mobile/cloud 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

The anticipated annualized base pay range this full time position working at this location will be from $100,700 to $191,300, plus annual bonus target (subject to plan eligibility and other requirements) and the value of core and optional employee benefits being offered at Boston Scientific (BSC), which can be reviewed at. At BSC, it is not typical for an individual to be hired near the bottom or top of the pay range
.

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

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.