Position Summary: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. This individual will work closely with spine 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
- Researching industry and direct competitors on an ongoing basis to ensure that Globus has cutting edge technology in all markets entered
- Adhering to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies. Ensure 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
- Representing 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 of Globus
In order to be qualified for this role, you must possess the following:- 3+ years of mechanical design engineering experience, preferably in the medical device field
- Bachelor's degree in Mechanical Engineering or similar area of study
- Proficiency in Creo software for design and drafting required
- Proven leader of people with strong self-starting skills
- Ability to work in fast paced environment; Multi-tasking abilities required for successful job completion
- Well organized, detail oriented and team player capable of working in a deadline dictated environment
- Ability to adequately represent and reflect company philosophy to customers, investors, regulatory agencies, and industry peers
- Proficient in preparation of reports and budgets
- Proficient in Microsoft Office
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.
