Methuen, MA, 01844, USA
20 hours ago
Group Manager EFLEX
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:** Our Enabling Technology Division is seeking an energetic and skilled Engineering Group Manager to oversee our ExcelsiusFlex orthopedic robotic system. In this role, you will be responsible for managing and executing all product launches, updates, and sustaining activities for the robotic platform at Globus Medical. This position combines managerial responsibilities with technical contributions, requiring hands-on involvement. Success in this role depends on effective leadership and collaboration with multiple cross-functional teams to meet shared goals. The ideal candidate will be a proactive team player, adaptable in a fast-paced and dynamic environment, with strong interpersonal skills, reliability, and a positive, composed demeanor. **Essential Functions:** + Successfully lead and manage the ExcelsiusFlex robotic platform for Globus Medical + Lead, manage and develop a small multi-disciplined product development team including electrical, mechanical, software, and systems engineering + Collaborate with the Total Knee Arthroplasty and Total Hip Arthroplasty application teams to launch new software, implant and instrumentation updates + Focus on rapid new product introductions to establish Globus as the leader in safety and innovation in the industry + Manage department specific sustaining efforts and complaints to maintain product performance and quality in the market + Lead the project portfolio including driving discipline to Globus Medical’s product development process, following design controls and maintaining device design history files + Recruit, hire, and train employees to fill positions as they arise and maintain a high-performance department + Responsible for all Quality Compliance activities for products within department including complaint, CAPA, MDR, NCMR, and all relevant compliance activities + Work closely with Regulatory Affairs in planning, coordination, writing, and execution of 510(k), IDE & PMA submissions and approvals + Represent the company in a professional manner to regulatory bodies, Medical Board of Directors, Clinical Investigator Groups, surgeons, and sales force + Development of sound electrical, mechanical, software, pre-clinical, and clinical data of scientific merit on all technologies developed + Work closely with marketing to coordinate product and company marketing efforts + Participate in management meetings on strategic initiatives and business planning _Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions._ **Qualifications:** + Bachelor’s Degree with 7-10 years of related business experience required or Master’s degree with 6-9 years of experience + Experience managing a small group of engineers + Excellent oral and written communication skills + Experience in new product introduction, design control process and lifecycle management + Strong project management skills + Must be able to deliver results while working to tight timelines + Have the ability to resolve complex issues + Solid experience in a highly technical and regulated industry + Working knowledge of Windows, Microsoft Office, E-mail, and Microsoft Project + Ability to travel up to 10-20% of the time + Familiar with the FDA 21 CFR, 510(k) process, and relevant standards, such as IEC 60601, 62304, 62366. + Responsive problem solver in resolving customer issues and meeting customer requirements. + Ability to work under minimum supervision with a high degree of organizational, technical, and business competence **Physical Demands:** The physical demands listed here are representative of those that must be met by an 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.
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