Biomedical Project Engineer

Project Engineer

Work Location: San Antonio, TX

Summary:

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.

Responsibilities:

• 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.

Qualifications:

• 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.