Senior Navigation Systems Engineering Manager

Jobtailor; Boston (MA); On-site; USD 120,000 - 190,000; Full time

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.

Skills

Multidisciplinary Systems Engineering

Surgical Navigation Systems

ISO 14971 Compliance

Model-Based Systems Engineering

Requirements Management

Design Reviews

Education

Bachelor’s or Master’s in Systems Engineering or related field

Tools

DOORS

Jama

Polarion

Python

LabVIEW

MATLAB

Job description

• Lead and develop a multidisciplinary systems engineering team responsible for the definition of system architecture


• Own the end‑to‑end requirements lifecycle, ensuring seamless flow‑down and traceability from clinical user needs


• Drive close 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.

Requirements

• 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+ 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.

Core Competencies

Demonstrates expertise in leading multidisciplinary systems engineering teams, managing the end-to-end requirements lifecycle, and ensuring compliance with regulatory standards. Proficient in Model-Based Systems Engineering and skilled in risk management for surgical navigation systems.

Highest-signal resume keywords

• Multidisciplinary Systems Engineering


• Surgical Navigation Systems


• Requirements Management Tools


• ISO 14971 Compliance


• Model-Based Systems Engineering

ATS Optimization Keywords

Hard Skills

• Systems Engineering Principles


• Product Development Lifecycle


• Statistical Methods


• Design Control Activities


• Risk Management


• Interface Specifications


• Design-For-Reliability Practices


• Technical Writing


• Sample Size Calculation


• Agile Methodology

Soft Skills

• Excellent Communication Skills


• Problem Solving


• Collaboration

Certifications & Qualifications

• CQE


• CQA


• Six Sigma

Industry Keywords

• Surgical Robotic Systems


• Class II Medical Devices


• Class III Medical Devices


• Embedded Systems


• Firmware Testing


• Electromechanical Systems

Tools & Technologies

• DOORS


• Jama


• Polarion


• Python


• LabVIEW


• MATLAB