Senior Project Engineer

Globus Medical•Audubon, PA

21d

About The Position

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. Position Summary : 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

Minimum five 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 Pro/E 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

Obtain market feedback from spine surgeons and other customers to determine functional and design specifications for new product development
Create and maintain project plans and FDA complaint Design history Files (DHF) for each project
Manage of all aspects of project to ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies
Design and develop instruments and implants using Pro/E software
Partner with in-house prototype shop and outside vendors for rapid prototyping and evaluation
Perform design verification and validation activities to ensure designs meet specifications
Partner with marketing and product managers to develop forecasts and market plans
Assist in the writing of regulatory applications to the FDA and other regulatory bodies.
Collaborate with the operations department to setup manufacturing and/or purchasing as appropriate for each project
Participate in product introductions through sales training, customer calls/visits, etc.
Maintain diligent post introduction monitoring to address and customer requests for changes
Research market and competition on an ongoing basis to ensure that Globus has cutting edge technology in all markets entered
Adhere 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
Represent 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
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.