PROJECT ENGINEERWe are seeking a dynamic and detail-oriented Project Engineer to join our Product Development team. This role is pivotal in driving projects from concept through commercialization. The ideal candidate will possess strong engineering skills and a passion for engaging with customers and cross-functional teams to deliver innovative and sustainable solutions.
Essential Functions:Key Responsibilities:- Product Development:
- Lead the design of endovascular products 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.
- Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.
- Ensures 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
- Represents 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
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Qualifications:- Bachelor's Degree in Mechanical Engineering, Bioengineering, Biomedical Engineering, or a similar field.
- 3+ years of experience in mechanical design engineering; medical device experience strongly preferred.
- Endovascular product design experience 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.
Physical Demands:The physical demands listed here are representative of those that must be met by and employee to successfully perform the essential functions of this job.
- Required to sit; climb or balance; and stoop, kneel, crouch or crawl
- Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds
Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus.
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.
