Staff Engineer, Spine

Globus Medical•Audubon, PA

18h

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 Staff 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 with spine surgeons and all other functions of the company to ensure high quality and on-time product introductions. This team player will have experience with multi-tasking in a high energy fast paced environment.

Requirements

Minimum seven years of mechanical design engineering experience, preferably in the medical device field.
Bachelor's Degree in Mechanical Engineering or Biomedical Engineering
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.
Working knowledge of 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.
Management 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 CREO software.
Working with in-house prototype shop and outside vendors for rapid prototyping and evaluation.
Performing design verification and validation activities to ensure designs meet specifications.
Working 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.
Working with the operations department to setup manufacturing and/or purchasing as appropriate for each project.
Assisting in product introductions through sales training, customer calls/visits, etc.
Maintaining diligent post introduction monitoring to address and customer requests for changes.
Researching market and competition on an ongoing basis to ensure that Globus has cutting edge technology in all markets entered.
Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies
Ensures 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
Represents the company in a professional manner and upholds the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.