At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible.
**Position Summary:**
We are seeking an experienced Systems Engineering and Hardware Systems Manager to lead a multidisciplinary team driving innovation in next-generation surgical navigation systems. This role requires deep expertise in mechanical and electrical engineering principles, ensuring robust hardware solutions and compliance with medical device standards while driving innovation in product development.
**Essential Functions:**
+ **Mechanical & Electrical System Design**
+ 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.
+ **Systems Architecture & 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.
+ **Leadership & Development**
+ 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.
+ **Process & Compliance**
+ 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.
+ **Innovation & Continuous Improvement**
+ 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.
_Reasonable accommodations may be made to enable individuals with disabilities to perform these_ essential _functions._
**Qualifications:**
+ 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.
+ Experience with surgical navigation or imaging systems and familiarity with robotics, sensors, and real-time control systems are preferred
+ 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.
**Physical Demands** **:**
The physical demands listed here are representative of those that must be met by and employee to successfully perform the essential functions of this job.
+ Required to sit; climb or balance; and stoop, kneel, crouch or crawl
+ Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds
+ Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus.
**Our Values** **:**
Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.
+ **Passionate about Innovation** : Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions.
+ **Customer Focused** : We listen to our customers' needs and respond with a sense of urgency.
+ **Teamwork** : Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.
+ **Driven** : We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.
**Equal Employment Opportunity** **:**
Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees' talents and support an environment that is inclusive and respectful.
**Other Duties** **:**
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.