Job Description
Essential Functions:- Obtains market feedback from surgeons and other customers to determine functional and design specifications for new product development
- Creates and maintains project plans and FDA complaint Design history Files (DHF) for each project
- Manages all aspects of assigned projects to ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies
- Designs and develops instruments and implants using Creo and SolidWorks software
- Partners with in-house prototype shop and outside vendors for rapid prototyping and evaluation
- Performs design verification and validation activities to ensure designs meet specifications
- Collaborates with marketing and product managers to develop forecasts and market plans
- Assists in the writing of regulatory applications to the FDA and other regulatory bodies
- Partners with the operations department to setup manufacturing and/or purchasing as appropriate for each project
- Participates in product introductions through sales training, customer calls/visits, etc.
- Maintains diligent post introduction monitoring to address and customer requests for changes
- Researches industry and direct competitors on an ongoing basis to ensure that Globus has cutting edge technology in all markets entered
- 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:- 3-7 years' experience in mechanical design engineering; Medical device experience strongly preferred
- Bachelor's Degree in Mechanical Engineering, Bioengineering, Biomedical Engineering or a similar degree
- Proficiency in Creo and/or SolidWorks software for design and drafting
- Well organized, detail oriented, and team player capable of working in a deadline driven environment
- Experience in preparing reports and managing project budgets
- Strong knowledge of Microsoft Office
- Ability to attend surgeries and/or labs
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
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.
