Sustaining Engineer

Work Location: Bexar County, Texas

Summary:

Seeking a Sustaining Engineer to support engineering functions for existing product lines in the tissue engineering and biomaterials space. This role focuses on continuous improvement, design and development of line extensions, manufacturing enhancements, and post-launch monitoring. The position requires collaboration with cross-functional teams to ensure product quality and lifecycle management.

Responsibilities:

• Drive engineering improvements for existing tissue-based biomaterial products, including ideation and implementation of line extensions and manufacturing enhancements.
• Conduct and analyze laboratory and preclinical studies to evaluate product performance and generate technical reports for strategic decision-making.
• Lead investigations into product issues, perform root cause analysis, and implement corrective and preventive actions to resolve complications.
• Execute design verification and validation activities to ensure compliance with regulatory and internal specifications.
• Develop and maintain comprehensive project documentation, including SOPs, protocols, reports, batch records, and technical files.
• Collaborate with manufacturing, quality, donor services, distribution, and supply chain teams to support product development and lifecycle management.
• Monitor post-launch product performance, gather field feedback, and initiate continuous improvement initiatives based on data trends.
• Present technical findings, risk assessments, and project updates to cross-functional teams and leadership, ensuring compliance with all relevant standards and codes.

Qualifications:

• 1-3 years of design engineering experience, preferably in tissue engineering or related fields.
• Bachelor’s or master’s degree in biomaterials, biomedical engineering, materials science and engineering, chemical engineering, tissue engineering, or a related discipline.
• Experience or familiarity with cGMP environments, manufacturing human cells, biologics, or biomaterials is advantageous.
• Demonstrated self-starter with strong organizational and detail-oriented skills.
• Ability to manage multiple projects simultaneously in a fast-paced environment.
• Team player with a track record of meeting deadlines and collaborating effectively.
• Proficient in designing and executing experiments and maintaining laboratory stewardship.
• Physical ability to sit, climb, balance, stoop, kneel, crouch, or crawl; regularly lift up to 10 pounds and occasionally up to 25 pounds; possess close, distance, color, peripheral vision, depth perception, and focus adjustment.

Published Category: Manufacturing & Technical Operations