Branch Medical Group · 2 months ago
GROUP ENGINEERING MANAGER - NAVIGATION HARDWARE
Methuen, MA
Full-time
Onsite
Director/Executive
8+ years expGlobus Medical is focused on delivering innovations that improve the quality of life for patients with musculoskeletal disorders. They are seeking an experienced Systems Engineering and Hardware Systems Manager to lead a multidisciplinary team in the development of next-generation surgical navigation systems, ensuring compliance with medical device standards and driving innovation in product development.
Health CareManufacturingMedicalMedical Device
Responsibilities
Lead development of hardware platforms, including mechanical and electrical subsystems, ensuring robust performance and reliability
Design and development of mechanical assemblies, precision components, and electromechanical systems
Drive electrical hardware design including PCB development, power systems, and sensor integration
Define system-level architecture with strong emphasis on hardware reliability and performance
Ensure seamless integration of mechanical and electrical subsystems into robust, reliable and cohesive surgical navigation platforms
Collaborate with software and clinical teams for full system integration
Drive requirements management, risk analysis, and design verification/validation
Recruit, mentor, and develop a high-performing team of systems and hardware engineers focused on mechanical, electrical, and integrated system design
Foster a culture of innovation, collaboration, accountability and compliance with medical device standards
Ensure timely delivery of milestones within budget and quality standards
Adhere to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies
Ensure compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance pertaining to the role
Represent the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties of Globus
Implement best practices in systems engineering, including requirements management, traceability, and design controls
Ensure compliance with medical device standards (ISO 13485, IEC 60601, etc.) and regulatory guidelines
Support design transfer from R&D to production under ISO 13485 and FDA guidelines
Identify emerging technologies and incorporate them into product roadmaps
Lead prototyping and feasibility studies for emerging navigation technologies
Foster a culture of creativity and technical excellence within the team
Promote IP development through patents and publications
Qualification
Required
Master's degree or PhD in Mechanical Engineering, Electrical Engineering, or related field
8+ years in systems engineering or hardware development with strong mechanical and electrical engineering background
3+ years in leadership roles within regulated industries (medical devices preferred)
Strong understanding of mechanical and electrical design principles
Expertise in mechanical design (CAD, tolerance analysis, materials) and electrical design (schematics, PCB layout, power systems)
Expertise in system architecture, integration, and lifecycle management
Proven track record in medical device development or other regulated industries
Knowledge of FDA 21 CFR Part 11, IEC 60601, and HIPAA compliance
Knowledge of risk management and regulatory submissions
Excellent leadership, communication, ability to lead cross-functional teams, and project management skills
Preferred
Experience with surgical navigation or imaging systems and familiarity with robotics, sensors, and real-time control systems
Company
Branch Medical Group
Branch Medical Group is manufactures medical implants and graphic cases.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
unknown2015-02-25Acquired
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