3-5 years in mechanical design engineering, preferably medical devices
Bachelor's in Mechanical, Bioengineering, Biomedical Engineering, or similar
Proficient in Creo software for design work
Organized, detail-oriented team player in deadline-driven settings
Experience managing project budgets and preparing reports
Strong knowledge of Microsoft Office Suite
Willingness to attend surgeries and laboratory settings
Responsibilities
Gather market feedback from surgeons and customers for product specifications
Create and update project plans and FDA complaint Design History Files
Oversee all project aspects for timely and compliant deliverables
Design instruments and implants using Creo software
Coordinate with prototype shops and vendors for rapid prototyping
Conduct design verification and validation to meet specifications
Collaborate with marketing for product forecasts and market strategies
Assist in writing regulatory submissions for the FDA and other bodies
Work with operations to establish manufacturing or purchasing for projects
Support product introductions through sales training and customer interaction
Monitor product post-introduction and manage customer feedback
Benefits
Healthcare benefits including medical, dental, and vision insurance
401(k) retirement plan with company matching
Flexible working hours and work-life balance initiatives
Continuous education and professional development opportunities
Employee wellness programs and company-sponsored events
Full Job Description
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. The Project Engineer will work with surgeons and all other functions of the company to ensure high quality and on-time product introductions.
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 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
In order to be qualified for this role, you must possess the following:
Three to five years of experience in mechanical design engineering; Medical device experience strongly preferred
Bachelor's Degree in Mechanical Engineering, Bioengineering, Biomedical Engineering or a similar degree
Proficiency in Creo software for design and drafting
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
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
About Globus Medical
Globus Medical is a medical device company that develops and manufactures products for patients with musculoskeletal disorders. The company's products include spinal implants, surgical instruments, and orthopedic implants. Globus Medical was founded in 2003 and is headquartered in Audubon, Pennsylvania. The company has a strong focus on research and development and has received numerous awards for its innovative products. Globus Medical is committed to improving patient outcomes and has a strong reputation for providing high-quality products and services.
