Staff Project Engineer, Spine
Job Classification: Full-time/Exempt
Department: Product Development
Reports To: Group Engineering Manager
Location: Audubon, PA
Date: January 2023
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.
The Staff Project Engineer is responsible for recommending operational objectives, policies, procedures and work plans to optimize his/her personal productivity. This includes bringing a product from concept to design, prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post-introduction monitoring.
- Collaborates with senior management to establish strategic plans and objectives
- Implements functional strategy and contributes to the development of organizational policies
- Oversees staff in the conceptualization, design, manufacturing and launch of products
- Develops sound mechanical, pre-clinical, and clinical data of scientific merit on all technologies developed
- Performs and maintains a market analysis for each assigned product segment to identify new offerings and line extensions
- Creates and maintains project plans and FDA compliant Design History Files (DHF) for each project
- Designs and develops instruments and implants using Pro/E software
- Works with in-house prototyping and outside vendors for rapid prototyping and evaluation
- Performs design verification and validation activities to ensure design meets specifications
- Works with marketing and product managers to develop forecast and market plans
- Assists in the writing of regulatory applications to the FDA and other regulatory bodies
- Works with operations to set up manufacturing and/or purchasing as needed for each project
- Supports product introductions though sales training, customer calls, visits, etc.
- 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 upholds 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.
- Bachelor’s Degree with 7 years of related experience; or Master’s Degree and 5 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 problem-solving skills
- Proficiency in using Microsoft Office products
- Familiarity with the FDA 21 CFR, 510(k) process, and standards, such as IEC 60601, 62304, 62366
- Ability to travel up to 20% of the time
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.
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 visual abilities including close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus
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.
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.
This job description has been approved by:
Hiring Manager: _________________________________________
HM Signature: ___________________________________________
HR Employee: ___________________________________________
HR Signature: ___________________________________________
Employee signature below indicates the employee's understanding of the requirements, essential functions and duties of the position.
Employee Name: ________________________________________
Employee Signature: _____________________________________