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.
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.
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