Project Engineer, Development

Globus Medical•Audubon, PA

21h

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 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 surgeons and all other functions of the company to ensure high quality and on-time product introductions.

Requirements

Two to seven 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 Parametric software or similar CAD 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
Ability to travel up to 5% of the time and attend surgeries/labs
Ability to attend surgeries and/or labs
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

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 Parametric 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
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.