Bachelor's degree in Mechanical Engineering, Bioengineering, Biomedical Engineering, or a similar field
7+ years of experience in mechanical design engineering; medical device experience preferred
Proficiency in CREO and/or SolidWorks for design and drafting
Proficiency in Microsoft Excel, PowerPoint, and Project for data analysis and project tracking
Well-organized and detail-oriented with strong analytical and problem-solving skills
Effective communication skills for cross-functional collaboration
Ability to thrive in both engineering and clinical environments, including operating rooms.
Responsibilities
Lead design and development of surgical instruments and implants using CAD software (CREO)
Create and maintain project plans and FDA-compliant Design History Files (DHF)
Manage all aspects of assigned projects ensuring timely completion and compliance
Perform design verification and validation activities for specifications
Obtain market feedback from surgeons to determine product functional and design specifications
Collaborate with marketing and product managers on forecasts and market plans
Support lifecycle management of commercialized products and address quality issues.
Benefits
Opportunity to work on cutting-edge medical devices
Collaborative environment across multiple departments
Direct engagement with surgeons and clinical settings
Involvement in the full product development lifecycle
Ability to influence product design through customer feedback
Full Job Description
Key Responsibilities:
Product Development: Lead the design and development of surgical instruments and implants using CAD software (CREO).Create and maintain project plans and FDA-compliant Design History Files (DHF) for each project. Manages 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. Perform design verification and validation activities to ensure designs meet specifications. Partner with in-house prototype shops and external vendors for rapid prototyping and evaluation. Assist in writing regulatory applications to the FDA and other regulatory bodies.
Customer Engagement: Obtain market feedback from surgeons and other customers to determine functional and design specifications for new product development. Participate in product introductions through sales training, customer calls/visits, and support surgical cases in the operating room, working directly with surgeons to gather real-time feedback and identify clinical opportunities for improvement. Maintain diligent post-introduction monitoring to address customer requests for changes and ensure customer satisfaction.
Cross-Functional Collaboration: Collaborate with marketing and product managers to develop forecasts and market plans. Partner with the operations department to set up manufacturing and/or purchasing as appropriate for each project. Research industry and direct competitors on an ongoing basis to ensure that Globus has cutting-edge technology in all markets entered.
Product Sustaining: Maintains diligent post-introduction monitoring to address customer requests for changes. Support lifecycle management of commercialized products by addressing quality issues, supply chain changes, and cost improvement initiatives. Drive design updates and documentation revisions as needed to maintain compliance and product performance. Collaborate with Quality, Regulatory, Manufacturing, and Supply Chain teams to evaluate and implement engineering changes. Proactively identify and communicate improvement opportunities based on customer feedback, internal testing, or supplier input.
Qualifications:
Bachelor's Degree in Mechanical Engineering, Bioengineering, Biomedical Engineering, or a similar field.
7+ years of experience in mechanical design engineering; medical device experience strongly preferred.
Proficiency in CREO and/or SolidWorks software for design and drafting.
Proficiency with CAD software (CREO or SolidWorks preferred) for mechanical design and documentation.
Proficiency with Microsoft Excel, PowerPoint, and Project for data analysis, presentations, and project tracking.
Well-organized, detail-oriented, and a team player capable of working in a deadline-driven environment.
Strong analytical and problem-solving skills with attention to detail.
Effective verbal and written communication skills for cross-functional collaboration.
Ability to thrive in both engineering and clinical environments, including operating rooms and cadaver 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.
