Senior Project Engineer

Globus Medical•Audubon, PA

34d

About The Position

The Senior 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.

Requirements

7+ 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

Responsibilities

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