Lead, Surgical Navigation Systems Engineering

Jobtailor

Boston (MA)

On-site

USD 120,000 - 190,000

Full time

14 days+

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Job summary

Jobtailor is seeking a Senior Lead Systems Engineer in Boston to direct a multidisciplinary team focused on surgical navigation systems. You will own architecture, requirements, risk management, and design controls across hardware, software, and clinical integration.

Ideal candidates have 7+ years in multidisciplinary systems engineering, with 5+ in surgical robotics or navigation systems, and experience guiding teams through complex medical device development under ISO 14971.

Qualifications

Bachelor’s or master’s degree in systems engineering, mechatronics, electrical engineering, or related field.
7+ years of experience in multidisciplinary systems engineering.
5+ years of experience in surgical robotic systems, surgical navigation systems or complex multidisciplinary medical devices.
3+ years of experience leading systems engineering teams.
Strong understanding of systems engineering principles and product development lifecycle (e.g., V-model, waterfall, Agile).
Experience with requirements management tools (e.g., DOORS, Jama, Polarion).
Excellent technical writing and communication skills.
Preferred: Experience with Class II or Class III medical devices.
Preferred: Knowledge of embedded systems, firmware/software testing, or electromechanical systems.
Preferred: Familiarity with test automation tools and scripting languages (e.g., Python, LabVIEW, MATLAB).
Preferred: Certification in CQE, CQA, or Six Sigma is a plus.
Proficient in sample size calculation and statistical methods for analyzing data.

Responsibilities

Lead and develop a multidisciplinary systems engineering team responsible for the definition of system architecture.
Own the end‑to‑end requirements lifecycle with traceability from clinical user needs.
Drive collaboration across hardware, software, controls, mechanical, clinical, and V&V teams.
Lead system architecture development for surgical navigation systems.
Lead system‑level risk management activities in accordance with ISO 14971.
Own and lead software subsystem requirements.
Accountable for execution of all design control activities.
Chair and lead system‑level design reviews, architecture reviews, and risk mitigation reviews.
Define, control, and maintain system and subsystem interfaces and interface specifications.
Drive the integration of design‑for‑reliability practices.
Partner with Human Factors Engineering and Clinical Engineering.
Lead standards and regulatory compliance efforts.
Collaborate with reliability and test engineering teams.
Support design transfer and product launch activities.
Utilize Model‑Based Systems Engineering and UML practices.
Investigate and document nonconformances, deviations, and test failures.
Interface with regulatory affairs, quality, manufacturing, and clinical teams.
Communicate system‑level risks, roadblocks, and opportunities to senior management.
Identify critical paths during product development, address bottlenecks and risks and facilitate problem solving across R&D teams.
Support project resource and schedule planning.