Project Engineer, BiologicsPosition Summary:The Biomaterials Project Engineer will be responsible for all engineering functions of their product lines, which may include stem cell-based therapies, allograft tissue, synthetic scaffolds, and other biologic products. This includes bringing a product from idea/concept through design, prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring.
Essential Functions:- Developing biomaterials for use in orthopedic applications and other therapeutic applications
- Developing methodology and protocols for in vivo animal studies as well as writing reports
- Performing design verification and validation activities to ensure designs meet specifications
- Obtaining market feedback from spine surgeons and other customers to determine functional and design specifications for new product development
- Creating and maintaining project plans and Design History Files (DHF) for each project
- Managing all aspects of project to ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies
- Assisting with product introductions through sales training, customer calls/visits, etc.
- Maintaining diligent post introduction monitoring to address and customer requests for changes
- Researching market and competition on an ongoing basis to ensure that Globus has cutting edge technology in all markets entered
- Adhering 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
- Representing 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
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Qualifications:- BS in a scientific related field and 3 years' experience; MA or PhD degree preferred
- Good documentation skills and the ability to write accurate test procedures/summaries/reports
- Demonstrated superior oral and written communication skills and the ability to communicate complex issues in a succinct and logical manner
- Demonstrated ability to generate innovative solutions to complex problems and effectively work with and communicate to key stakeholders
- Ability to travel 10-15%
- Will be required to attend surgeries and/or 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.
