Project Engineer Tissue

Project Engineer – Tissue Product Development Location: San Antonio, Texas

Purpose The Project Engineer will support both existing and new tissue-based products through comprehensive project management and product development. This includes responsibilities spanning product design, prototyping, testing, manufacturing scale-up, and marketing—ensuring all activities align with regulatory standards and company objectives.

Key Responsibilities

• Lead end-to-end product development projects from concept through market launch, managing timelines, budgets, and cross-functional coordination.
• Ensure all development activities comply with design control processes and regulatory requirements (FDA, AATB, ISO).
• Gather and integrate customer and market feedback to guide product design and improvement.
• Collaborate with QA and Operations to develop scalable manufacturing processes and oversee technology transfer.
• Drive validation efforts: develop and execute protocols, interpret data, and prepare comprehensive validation reports in compliance with applicable standards (e.g., FDA 21 CFR 820, ISO 13485, ASTM, AAMI).
• Support regulatory submissions, quality investigations, and creation of compliant SOPs and training materials.
• Analyze product cost structures and support continuous improvement across existing and new product lines.
• Contribute to onboarding of proprietary equipment and support broader operational initiatives including supply chain and distribution readiness.
• Assist with the development of sales and marketing materials and ensure alignment of product claims with regulatory and market positions.

Skills

• Strong project management experience, with the ability to drive initiatives independently and within teams.
• Technical writing proficiency with the ability to present complex concepts clearly.
• Understanding of manufacturing environments, validation procedures, and regulatory compliance.
• Excellent analytical, creative thinking, and problem-solving skills.
• Comfortable working in a dynamic, fast-paced environment.
• Proficient in Microsoft Office; experience with CAD software is a plus.
• Experience engaging with vendors and external partners.

Qualifications/Requirements

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related field (required).
• Minimum of 3 years of project management experience in a regulated environment.
• Experience in mechanical design and CAD software.
• Background in engineering or biological sciences preferred.
• Prior exposure to medical products, allografts, or medical devices is highly desirable.
• Familiarity with FDA, AATB, ISO, and cGMP/CGTP standards.
• Successful completion of a favorable background investigation (required).
• Flexibility to work outside of standard hours as needed to support project timelines or operational needs.
• Demonstrated ability to complete responsibilities within defined timeframes and meet attendance requirements.