Principal System Design Engineer

• Direct the technical team in defining system architecture, managing interfaces, and overseeing both physical and functional designs. Provide system-level expertise for integrating hardware and software from global sources while supporting collaboration and decision-making with internal and external teams.

• Collaborate with peers to design and deliver technical solutions across various projects, including but not limited to system architecture, system design, implementation, integration, and testing for complex, connected electronic medical equipment systems and systems-of-systems in accordance with product development procedures.

• Identify and address system issues using simulation, mathematical analysis, characterization and system interaction testing, and provide recommendations for corrective actions. Oversee technical project progress by troubleshooting, communicating status to stakeholders, and supporting timely resolution.

• Guide process improvements within systems engineering and contribute to AI-driven patient management and healthcare solutions.

• Facilitate safety and security analyses to ensure compliance and risk mitigation. Mentor engineers by sharing best practices and domain knowledge and provide technical input for leadership decisions.

• Make ongoing adjustments to processes and methodologies through collaboration with peers and cross functional groups, analyzing activities to enhance workflow and work processes.

• Manage third party designers, vendors, and contractors to deliver engineering solutions efficiently.

• Demonstrate practical understanding of project management concepts and experience with Agile methodologies, including scrums.

• Degree in mechanical, electrical, computer science, systems engineering, or a related field.

• 10+ years of experience with a bachelor’s degree, or 8+ years with a master’s or 4+ years with PhD, in medical device systems engineering and leading complex Class II/III programs.

• Proficient in requirement management tools (JAMA, DOORS, Cognition COCKPIT) and product lifecycle tools (JIRA, Windchill).

• Expert in medical device design controls, including user needs, intended use, system requirements, design, and requirements traceability.

• Proven leadership in cross-functional teams, stakeholder alignment, and balancing technical and business goals.

• Successful record in developing system/product requirements, verification/validation, and regulatory compliance for global markets.

• Effective collaborator in fast-paced, global environments.

• Up to 10% travel to BSC divisions and clinics.

Preferred Qualifications:

• Possesses an MS, PhD, or equivalent advanced business leadership training in Systems Engineering, Electrical Engineering, Software Engineering, or a related discipline.

• Holds INCOSE CSEP certification or an equivalent professional credential.

• Experienced in system modeling languages, including SysML, Arcadia, UML, OPM, or comparable frameworks.

• Recognized for leadership through awards or significant contributions to innovation, cross-functional collaboration, and process optimization within systems engineering.

• Demonstrates expertise in risk management and DFMEA, with a proven ability to identify and implement effective risk controls.

• Proficient in cybersecurity design principles, with hands-on experience specifying and facilitating their integration.

• Successfully led project teams on high-impact, high-priority technological initiatives.

• Familiar with quality systems and experienced with IEC and ISO standards pertaining to the medical device software lifecycle and risk management (specifically IEC 62304).

• Proven track record of strong cross-functional collaboration, influence without formal authority, and project management that fosters highly effective project teams.

• Self-motivated individuals who proactively address critical issues, ambiguous requirements, and loosely defined challenges, consistently mobilizing teams to deliver business outcomes.

• Demonstrated ability to quickly learn new platforms and development environments to align with evolving project objectives.

• Excellent verbal, written, and interpersonal communication capabilities, with a history of effective problem resolution.

• Highly developed communication and time management skills.

• Extensive experience collaborating with global, distributed teams.