Project Engineer, Development

Responsibilities

• Obtaining market feedback from surgeons and other customers to determine functional and design specifications for new product development
• Create and maintain project plans and FDA complaint 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
• Design and develop instruments and implants using Creo Parametric software
• Partner with in-house prototype shop and outside vendors for rapid prototyping and evaluation
• Perform design verification and validation activities to ensure designs meet specifications
• Collaborate with marketing and product managers to develop forecasts and market plans
• Aid in the writing of regulatory applications to the FDA and other regulatory bodies
• Partner with the operations department to setup manufacturing and/or purchasing as appropriate for each project
• Participate in product introductions through sales training, customer calls/visits, etc.
• Maintain diligent post introduction monitoring to address customer requests for changes
• Research industry and direct competitors on an ongoing basis to ensure that Globus has cutting edge technology in all markets entered
• Adhere 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
• Represent 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

• Two to seven years of mechanical design engineering experience, preferably in the medical device field
• Bachelor's degree in Mechanical Engineering or similar area of study
• Proficiency in Creo Parametric software or similar CAD software for design and drafting required
• Proven leader of people with strong self-starting skills
• Ability to work in fast paced environment; Multi-tasking abilities required for successful job completion
• Well organized, detail oriented and team player capable of working in a deadline dictated environment
• Ability to adequately represent and reflect company philosophy to customers, investors, regulatory agencies, and industry peers
• Proficient in preparation of reports and budgets
• Proficient in Microsoft Office
• Ability to travel up to 5% of the time and attend surgeries/labs
• Ability to attend surgeries and/or labs

Qualifications

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.