- Cambridge, Massachusetts, United States
- Hybrid
- Full-time · Senior
- 8+ years
Lead systems engineering across the Spectris AD product development lifecycle, from requirements definition through commercialization and post-market support.
Responsibilities
- Lead systems engineering activities for Spectris AD across the medical device development lifecycle
- Owns the definition, development, and delivery of product features and clinical applications
- Drives technical risk identification and retirement while ensuring compliance with applicable quality, regulatory, cybersecurity, and safety requirements
- Leads cross-functional development teams spanning engineering, clinical, quality, regulatory, product management, manufacturing, service, and commercial organizations
- Ensures requirements flow-down and traceability from patient, caregiver, and clinician needs through system, subsystem, and component level specifications
Requirements
- BS in engineering, computer science, biomedical engineering, electrical engineering, mechanical engineering, or a related technical discipline
- Nice to have: advanced degree
- Nice to have: experience with neurotechnology
- Nice to have: experience with wearable or home use medical devices
- Nice to have: experience with connected device and companion application architectures