DIRECTOR OF PRODUCT DEVELOPMENT, CERVICAL - Globus Medical, Inc.
Audubon, PA
About the Job
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:
The Director, Product Development oversees the design and development of medical devices. This effort includes the investigation and evaluation of existing medical device technologies and the conceptualization of new methodologies, materials, machines, processes, or products. The Director, Product Development also leads the development of new concepts from initial design to market release, managing feasibility studies of the design to determine if capable of functionality as intended.
Essential Functions:
+ Collaborates with senior management to establish strategic plans and objectives
+ Cascades functional strategy and contributes to the development of organizational policies
+ Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people
+ Makes decisions on implementation and ensures operational effectiveness
+ Ensures budgets and schedules meet corporate requirements
+ Oversees staff in the conceptualization, design, manufacturing and launch of products
+ Works on complex issues where problems are not clearly identified and where fundamental principles do not fully apply
+ Accountable for how actions impact function or department budget
+ Monitors documentation maintenance throughout all phases of research and development
+ Represents company and function during agency audits
+ Establishes process capabilities and baseline performance through process studies
+ Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies. Ensures 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 as it applies to your role
+ Represents 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
_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 experience; or Master’s Degree and 5-7 years of experience
+ Excellent verbal and written communication skills
+ Advanced project management skills
+ Experience with new product introduction and lifecycle management
+ Advanced critical thinking and problems-solving skills
+ Experience working in a highly technical and regulated industry
+ Proficiency in using Microsoft Office products
+ Familiarity with the FDA 21 CFR, 510(k) process, and relevant standards, such as IEC 60601, 62304, 62366
+ Ability to function well under tight timelines and pressure
+ Experience with medical capital electro-mechanical systems
+ Ability to work with limited supervision
+ Ability to travel up to 20% of the time
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.
Position Summary:
The Director, Product Development oversees the design and development of medical devices. This effort includes the investigation and evaluation of existing medical device technologies and the conceptualization of new methodologies, materials, machines, processes, or products. The Director, Product Development also leads the development of new concepts from initial design to market release, managing feasibility studies of the design to determine if capable of functionality as intended.
Essential Functions:
+ Collaborates with senior management to establish strategic plans and objectives
+ Cascades functional strategy and contributes to the development of organizational policies
+ Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people
+ Makes decisions on implementation and ensures operational effectiveness
+ Ensures budgets and schedules meet corporate requirements
+ Oversees staff in the conceptualization, design, manufacturing and launch of products
+ Works on complex issues where problems are not clearly identified and where fundamental principles do not fully apply
+ Accountable for how actions impact function or department budget
+ Monitors documentation maintenance throughout all phases of research and development
+ Represents company and function during agency audits
+ Establishes process capabilities and baseline performance through process studies
+ Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies. Ensures 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 as it applies to your role
+ Represents 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
_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 experience; or Master’s Degree and 5-7 years of experience
+ Excellent verbal and written communication skills
+ Advanced project management skills
+ Experience with new product introduction and lifecycle management
+ Advanced critical thinking and problems-solving skills
+ Experience working in a highly technical and regulated industry
+ Proficiency in using Microsoft Office products
+ Familiarity with the FDA 21 CFR, 510(k) process, and relevant standards, such as IEC 60601, 62304, 62366
+ Ability to function well under tight timelines and pressure
+ Experience with medical capital electro-mechanical systems
+ Ability to work with limited supervision
+ Ability to travel up to 20% of the time
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.
Source : Globus Medical, Inc.