Biomedical Project Engineer

The Project Engineer provides technical expertise to support the development and optimization of allograft products for clinical applications, focusing on research, process improvement, and compliance with regulatory standards.

• Lead and execute allograft processing activities, including tissue characterization and process troubleshooting.
• Design and implement experimental protocols, analyze data, and prepare comprehensive technical reports.
• Optimize and validate manufacturing processes to ensure adherence to quality standards and regulatory requirements.
• Train and support manufacturing teams in transferring R&D processes to production, including qualifications and post-launch improvements.
• Maintain detailed experimental records and draft technical documentation such as SOPs, protocols, and regulatory submissions.
• Ensure compliance with FDA, AATB, and GMP standards throughout product development and manufacturing processes.
• Monitor advancements in allograft technologies and contribute to ongoing innovation within the field.
• Uphold ethical business practices and maintain compliance with all relevant laws, regulations, and internal policies.

• Bachelor’s or Master’s degree in Biology, Biomedical Engineering, Biomedical Sciences, or a related field.
• Experience in process development, manufacturing, analytical testing, and/or quality systems for allograft (hands-on preferred).
• Proficiency in designing and executing protocols for qualification and validation activities.
• Exceptional communication and problem-solving skills.
• Comprehensive knowledge of GMP, FDA, and AATB regulatory requirements.
• Strong organizational skills with experience in documentation, data tracking, and regulatory compliance.
• Prior tissue banking and/or wet lab experience, as well as industry experience, strongly preferred.