The Systems Architect is responsible for defining and maintaining the system-level architecture for assigned company products and platforms. This role ensures that product requirements, subsystem interfaces, technical decisions, and integrated design solutions support product performance, safety, usability, reliability, manufacturability, and regulatory compliance. The Systems Architect holds primary authority over system-level technical decisions, ensuring design integrity and alignment across the platform throughout the product lifecycle.
Responsibilities
- Work in close partnership with platform leadership to support and lead platform success
- Provide overall technical direction and decision-making for technical aspects of the platform
- Define, document, and maintain system architecture for assigned products and platforms, including subsystem interaction, interfaces, design assumptions, constraints, and technical rationale
- Translate user, clinical, business, and product requirements into system-level architecture, requirements allocations, and integrated technical solutions
- Lead systems engineering activities including requirements decomposition, interface definition, risk identification, tradeoff analysis, and integration planning
- Partner with cross-functional engineering teams to ensure subsystem designs align with overall system intent and platform strategy
- Support product development activities from concept through launch, including architecture development, design reviews, prototyping, verification/validation planning, and sustaining engineering
- Drive technical risk management activities, identifying system-level risks and supporting mitigation planning across the development lifecycle
- Lead or support system integration efforts, root-cause analysis, and resolution of complex product performance or reliability issues
- Collaborate with Quality and Regulatory teams to ensure architecture and systems engineering outputs support design controls, traceability, risk management, and regulatory expectations
- Develop and maintain system-level documentation including architecture descriptions, interface definitions, requirements traceability inputs, design analyses, and technical assessments
- Evaluate design changes and new technologies for impact to system performance, integration, risk, and compliance
- Provide technical leadership in support of external engineering partners, contract developers, and related third-party contributors
- Support platform and project teams by providing recommendations on architecture, integration strategy, and technical execution priorities
- Participate in design reviews, failure investigations, CAPA-related technical assessments, and continuous improvement initiatives
- Mentor engineers and contribute to development of systems engineering discipline and best practices within the company
- Other duties as assigned.
- Additional Functions
- Support definition of long-range technical roadmaps and next-generation product concepts
- Contribute to internal standards, templates, and methods for systems engineering and architecture management
- Provide technical input during strategic product, platform, and innovation discussions
Qualifications
Education/Training/ Certifications/Licenses:
- Bachelor’s Degree in Engineering
Experience:
- Minimum 8 years of engineering experience in medical device development and/or similarly regulated product development environment
- Demonstrated experience in systems engineering, product architecture, or multidisciplinary product integration
- Experience with complex electro-mechanical and/or software-enabled devices strongly preferred
- Experience with design controls, requirements management, verification/validation, and risk management in regulated environments required
- Experience supporting root-cause analysis, failure investigation, and product changes across the lifecycle preferred
- Experience working with external development and manufacturing partners
Skills/Abilities:
- Strong system-level thinking and ability to connect user needs, requirements, architecture, and execution
- Strong technical judgment and ability to evaluate complex tradeoffs across disciplines
- Ability to lead through influence and collaborate effectively across cross-functional teams
- Strong documentation, analytical, and problem-solving skills
- Ability to communicate complex technical concepts clearly to varied audiences
- Familiarity with tools and methods supporting systems engineering, requirements management, risk analysis, and design documentation
- Working knowledge of regulated medical device development expectations, including FDA and ISO 13485 frameworks