Project Engineer

Globus Medical•Audubon, PA

41d•Onsite

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. 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 compliant 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 Pro/E 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 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 Coordination 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

Requirements

Three to seven years’ experience in mechanical design engineering; Medical device experience strongly preferred
Bachelor’s Degree in Mechanical Engineering, Biomedical Engineering or a similar degree
Proficiency in Pro/E software or similar CAD software for design and drafting; knowledge of GD&T
Knowledge of risk analysis techniques
Strong verbal and written communication skills
Well organized, detail oriented, and team player capable of working in a deadline driven environment
Experience in preparing reports and managing project budgets
Strong knowledge of Microsoft Office
Ability to attend surgeries and/or labs

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 compliant 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 Pro/E 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
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
Coordination 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