Position Summary:
The Project Engineer will offer technical support for the advancement of allograft product development. This role entails conducting research and development, as well as optimizing processes to produce grafts for use in clinical applications including, but not limited to, spine and orthopedic surgery. Responsibilities include developing, optimizing, and validating manufacturing processes to uphold quality standards. Candidates must hold a Bachelor’s or Master’s degree in Biomedical Engineering, Biomedical Sciences, or a related field. Prior tissue banking and/or wet lab experience as well as industry experience strongly preferred.
Job Responsibilities:
- Conducts allograft processing activities and tissue characterization
- Designs and executes experimental protocols, collects and analyzes data, and provides comprehensive reports on findings
- Performs and troubleshoots processes and analytical techniques
- Trains and supports manufacturing personnel in tech transfer of R&D processes to production scale, including qualifications, validations, and post-launch improvements
- Maintains meticulous experimental records, drafts detailed technical reports, and ensures strict compliance with applicable quality and regulatory standards
- Possesses in-depth knowledge of FDA and AATB regulatory requirements for allografts, ensuring full compliance with GMP standards in product development and manufacturing
- Authors and reviews a variety of technical documents, including SOPs, protocols, regulatory submissions, patents, and scientific publications, ensuring clarity and accuracy
- Stay updated on emerging trends and advancements in allograft technologies and actively contributes to innovation within the Regenerative Biologics Division
- 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 upholds 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 theseessentialfunctions.
Qualifications:
- B.S. or M.S. in Biology, Biomedical Engineering, Biomedical Sciences, or a related field required
- Experience in process development, manufacturing, analytical testing, and/or quality systems for allograft (hands-on preferred)
- Proficient in protocol design and execution for qualification/validation activities
- Exceptional communication and problem-solving skills required
- Comprehensive knowledge of GMP, FDA, and AATB regulatory requirements
- Strong organizational skills with demonstrated experience in documentation, data tracking, and regulatory compliance
Physical Demands:
The physical demands listed here are representative of those that must be met by an 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 25 pounds and occasionally lift and/or move up to 65 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.
