Position Summary :The Principal Engineer, Systems serves as the technical leader for assigned product lines, defining system architecture, engineering strategy, and technology direction across the full product lifecycle. This role provides systems engineering leadership for complex medical devices, guiding development from concept through commercialization while ensuring alignment with customer needs, regulatory requirements, business objectives, and long-term platform strategy.
As a senior technical authority, the Principal Engineer collaborates across engineering, clinical, quality, regulatory, manufacturing, and commercial teams to develop innovative, scalable, and commercially successful products while driving engineering excellence and systems-level best practices across the organization.
Responsibilities:- Define and drive systems engineering strategy, architecture, technical standards, and technology roadmaps across assigned product lines.
- Lead system architecture development and integration activities, ensuring alignment of requirements, interfaces, technologies, and product platforms.
- Guide technical decision-making through system-level analyses, trade studies, and risk assessments that balance performance, quality, manufacturability, cost, schedule, and business objectives.
- Establish and maintain system requirements, interface definitions, and technical specifications in collaboration with multidisciplinary engineering teams.
- Lead Safety Risk Management activities and ensure risks are appropriately identified, evaluated, mitigated, and documented throughout product development.
- Ensure engineering activities comply with design controls, verification and validation requirements, quality standards, and applicable regulatory requirements.
- Partner with Quality and Regulatory teams to support FDA, CE, and other global regulatory submissions and compliance activities.
- Provide technical leadership and mentorship across engineering teams, serving as a trusted advisor for complex system-level challenges.
- Collaborate with clinical, commercial, and business stakeholders to translate customer and clinical needs into product and technology strategies.
- Evaluate emerging technologies and industry trends to identify opportunities for future products, platforms, and innovation initiatives.
- Support portfolio planning by assessing technical feasibility, development risks, resource needs, and strategic opportunities.
- Represent the company in technical, clinical, and industry forums and build relationships with external technology and clinical partners.
- Drive continuous improvement of systems engineering processes, methodologies, tools, and best practices.
Required Qualifications- Master's or PhD in Electrical Engineering, Physics, Computer Science, Systems Engineering, or a related technical discipline.
- 15+ years of progressive engineering experience with significant systems engineering, product development, and technical leadership responsibility.
- Demonstrated success leading complex product development programs from concept through commercialization within a regulated environment.
- Deep knowledge of systems engineering principles, including system architecture, requirements management, system integration, verification, validation, and risk management.
- Strong understanding of medical device design controls and applicable regulatory requirements, including FDA and international standards.
- Proven ability to influence technical direction and lead cross-functional teams without direct authority.
- Exceptional analytical, problem-solving, communication, and decision-making skills.
- Demonstrated ability to mentor engineers, build technical capability, and influence organizational engineering strategy.
Preferred Qualifications- Medical device industry experience involving complex electromechanical, software-driven, robotic, navigation, imaging, or surgical systems.
- Experience with FDA submissions, global product registrations, and regulatory interactions.
- Working knowledge of ISO 14971 and related medical device standards.
Our Values:Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.
- Passionate about Innovation: Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions.
- Customer Focused: We listen to our customers' needs and respond with a sense of urgency.
- Teamwork: Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.
- Driven: We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.
Other Duties:Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
