Senior Navigation Systems Engineering Lead (MedTech)

Antler; Boston (MA); On-site; USD 137,000 - 236,000; Full time

Benefits offered by this job

Vacation -120 hours/year

Sick time - 40 hours/year

Holiday pay - 13 days/year

Parental Leave - 480 hours

Job summary

Johnson & Johnson’s Orthopaedics division is hiring a Senior Navigation Systems Engineering Manager in a hybrid role based in Raynham or Boston, MA. The role leads a multidisciplinary team across hardware, software, and clinical workflows to deliver a compliant, high‑performing navigation system.

The position emphasizes end‑to‑end requirements flow, design control per FDA/ISO, and collaboration with HF, Clinical, Quality, and Manufacturing teams to ensure safe and effective product launches.

Qualifications

• Bachelor’s or master’s degree in systems engineering or related field.
• 7+ years in multidisciplinary systems engineering.
• 5+ years in surgical navigation systems or complex medical devices.
• 3+ years leading systems engineering teams.
• Experience with requirements management tools (DOORS, Jama, Polarion).
• Excellent technical writing and communication skills.

Responsibilities

• Lead multidisciplinary systems engineering teams to define architecture and requirements for a surgical navigation platform.
• Own end‑to‑end requirements lifecycle with traceability from clinical needs to verification and validation.
• Collaborate across hardware, software, controls, mechanical, clinical and V&V teams to ensure testable system requirements.
• Lead system architecture development and integration of hardware, software, and controls for a safety‑critical medical device.
• Own system‑level risk management per ISO 14971 including hazard analysis and residual risk assessment.
• Drive design reviews and regulatory submissions readiness through stringent design controls.

Skills

Systems engineering

Leadership

Technical writing

Communication

Regulatory understanding

Education

Bachelor’s or Master’s degree in systems engineering or related field

Tools

DOORS

Jama

Polarion

MBSE

Job description

Johnson & Johnson’s Orthopaedics division is hiring a Senior Navigation Systems Engineering Manager in a hybrid role based in Raynham or Boston, MA. The role leads a multidisciplinary team across hardware, software, and clinical workflows to deliver a compliant, high‑performing navigation system.

The position emphasizes end‑to‑end requirements flow, design control per FDA/ISO, and collaboration with HF, Clinical, Quality, and Manufacturing teams to ensure safe and effective product launches.