Sr Project Engineer

Key Responsibilities

• 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.
• Manage 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.
• Affix regulatory applications to the FDA and other regulatory bodies.
• 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.
• 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.
• Maintain 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.