The Project Engineer will be responsible for all engineering functions of their product lines. This includes bringing a product from idea/concept through design, prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring. The Project Engineer will work with surgeons and all other functions of the company to ensure high quality and on-time product introductions.
The responsibilities of the position include, but are not limited to, the following:- Obtaining market feedback from surgeons and other customers to determine functional and design specifications for new product development
- Creating and maintaining project plans and FDA complaint Design history Files (DHF) for each project
- Managing 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
- Designing and developing instruments and implants using Creo software
- Partnering with in-house prototype shop and outside vendors for rapid prototyping and evaluation
- Performing design verification and validation activities to ensure designs meet specifications
- Collaborating with marketing and product managers to develop forecasts and market plans
- Assisting in the writing of regulatory applications to the FDA and other regulatory bodies
- Partnering with the operations department to setup manufacturing and/or purchasing as appropriate for each project
- Participating in product introductions through sales training, customer calls/visits, etc.
- Maintaining diligent post introduction monitoring to address and customer requests for changes
- In order to be qualified for this role, you must possess the following:
- Three to five years of 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 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
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.
