Navigation Systems Software Manager

Jobtailor; Boston (MA); On-site; USD 140,000 - 200,000; Full time

Job summary

Jobtailor in Boston seeks a senior embedded software engineer to lead the full lifecycle development of software subsystems for surgical navigation platforms, from concept through verification, release, and post‑market support. Define the platform architecture to ensure real‑time performance, safety, cybersecurity, and long‑term maintainability.

Collaborate with systems, hardware, clinical, usability, quality, and manufacturing teams to translate needs into testable requirements.

Qualifications

• 7+ years of hands‑on embedded software experience in medical devices.
• Strong C/C++ development across drivers, middleware and applications.
• Experience with safety‑critical software and regulatory expectations.

Responsibilities

• Lead full lifecycle development of embedded subsystems for surgical navigation platforms.
• Define and evolve platform architecture for real‑time performance and maintainability.
• Establish software roadmaps aligned with product strategy and system evolution.
• Ensure designs meet requirements, hazard mitigations, and regulatory expectations.
• Collaborate with systems, hardware, clinical and quality teams to derive testable requirements.
• Lead architecture and design reviews and cross‑disciplinary trade‑offs.
• Develop safe, intuitive user interfaces with clinical teams.
• Support regulatory submissions, audits, and DHF completeness with quality and regulatory teams.
• Establish DevOps strategies for regulated embedded devices, including CI, change control, and source management.
• Promote automated testing, metrics‑driven development, and RCA for continuous improvement.
• Lead software FMEA activities and risk mitigation aligned with system requirements.
• Contribute to hazard analysis, risk management, and design controls per medical device standards.
• Drive design transfer, manufacturing readiness, and product launch activities.
• Mentor and grow a high‑performing embedded software team.

Skills

Embedded C/C++ development

RTOS experience

Windows/.NET development

Python scripting

Software architecture & design

Regulatory/compliance awareness

Education

Bachelor’s or Master’s degree in Software/Electrical/Computer Engineering

Tools

DOORS

Jama

Polarion

LabVIEW

MATLAB

QNX

Job description

Responsibilities

• Lead the full lifecycle development of embedded software subsystems for surgical navigation systems platforms, from early concept and prototyping through verification, release, and post‑market support.
• Define, own, and evolve the embedded software platform and architecture, ensuring scalability, real‑time performance, safety, cybersecurity, and long‑term maintainability.
• Establish technical direction and software roadmaps aligned with product strategy and system evolution.
• Ensure software designs are compliant with system requirements, user needs, intended use, hazard mitigations, and regulatory expectations.
• Partner with systems engineering, hardware, clinical, usability/human factors, quality, and manufacturing teams to translate user needs into clear, testable, traceable software requirements.
• Lead and participate in architecture reviews, design reviews, and cross‑disciplinary technical trade‑off discussions.
• Collaborate on the design and implementation of safe, intuitive user interfaces with human factors and clinical teams.
• Support regulatory submissions, audits, inspections, and DHF completeness in partnership with quality and regulatory affairs.
• Establish and own DevOps strategies appropriate for regulated embedded surgical robotics and navigation systems, including:
  • Continuous Integration (CI) with automated builds, static analysis, and test execution
  • Controlled release pipelines aligned with design controls and change management
  • Source control, branching strategies, and configuration management for safety‑critical products
• Lead adoption of automated unit‑testing, integration, and system‑level testing to improve quality and delivery predictability.
• Champion metrics‑driven development (build health, test coverage, defect trends) to drive continuous improvement.
• Lead software FMEA activities, define and verify effective risk mitigation strategies, and ensure software safety levels align with system requirements and applicable risk controls.
• Contribute to hazard analysis, risk management, and design controls in accordance with medical device regulations.
• Ensure compliance with applicable medical device software standards (e.g., IEC 62304) and internal quality processes.
• Investigate non‑conformances, deviations, and test failures; drive root cause analysis (RCA) and corrective actions.
• Lead software planning and execution across development phases, including prototyping, design, verification, validation, and release.
• Support design transfer, manufacturing readiness, and product launch activities.
• Participate in complaint investigations, post‑market surveillance, and controlled software updates.
• Build, mentor, and retain a high‑performing embedded software team.
• Identify project critical paths, proactively manage risks, and facilitate cross‑functional problem solving.
• Support resource planning, staffing, and schedule estimation.
• Communicate risks, opportunities, and execution status clearly to senior leadership.
• Foster a culture of technical excellence, accountability, ownership, and continuous improvement.
• Communicate business‑related issues, risks, and opportunities to senior management in a timely and effective manner.

Requirements

• Bachelor’s or Master’s degree in Software Engineering, Electrical Engineering, Computer Engineering, or a related technical discipline.
• Minimum of 7+ years of hands‑on experience developing embedded software for medical devices.
• Deep expertise in embedded C/C++ development, including low‑level drivers, middleware, and application‑level software.
• Expertise in Microsoft .NET development framework and Window based applications
• Strong experience with real‑time embedded systems, including RTOS‑based environments (e.g., QNX or similar real‑time operating systems).
• Strong understanding of software and 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.
• Experience with Class II or Class III medical devices is preferred.
• Familiarity with test automation tools and scripting languages (e.g., Python, LabVIEW, MATLAB).