- Company Name
- Smith+Nephew
- Job Title
- Staff System Architect (Andover, MA)
- Job Description
-
**Job title**
Staff System Architect
**Role Summary**
Lead the systems engineering effort for next‑generation surgical visualization products in the Sports Medicine domain. Provide technical leadership, define architecture, drive integration, and ensure compliance with medical device standards.
**Expectations**
• Own end‑to‑end product development lifecycle from concept through pre‑clinical/clinical evaluation.
• Act as systems engineering lead, managing a team of systems engineers.
• Interface directly with users, stakeholders, and R&D to capture requirements and communicate decisions.
• Champion systems engineering best practices and continuous improvement.
**Key Responsibilities**
- Define system architecture (functional, physical, interfaces) and decompose complex problems into actionable subsystems.
- Develop and maintain requirements traceability, use cases, user stories, and verification strategies.
- Lead trade studies, architecture reviews, and integration planning.
- Oversee integration, stress testing, and pre‑clinical/clinical evaluations, including human‑factors assessments.
- Provide guidance to R&D to align detailed design with the approved architecture.
- Ensure compliance with IEC 62304, ISO 14971, IEC 60601‑1/2‑18, FDA, MDD, ISO/FDA endoscopy guidelines, and cybersecurity standards.
- Manage requirements with Cognition Cockpit or similar tools; model-based engineering with Enterprise Architect or equivalent.
**Required Skills**
- 10+ years systems engineering/product development on complex software‑driven electro‑mechanical medical devices.
- Proven leadership of integrated, cross‑functional R&D teams.
- Expertise in requirement decomposition, interface management, and integration testing.
- Strong understanding of medical device regulatory processes and standards.
- Experience with embedded systems and optics in medical applications.
- Familiarity with image‑quality metrics, ISO/FDA consensus guidelines for endoscopy, and medical device cybersecurity.
- Proficient with Cognition Cockpit, Enterprise Architect, or similar modeling and requirements tools.
**Required Education & Certifications**
- Bachelor’s degree in Computer Science, Software Engineering, Electrical Engineering, Biomedical Engineering, Mechanical Engineering, or related field.
- Preferred Master’s in Systems Engineering or formal systems engineering training.
- INCOSE ASEP or CSEP certification preferred.