Job Summary:
Seeking a Tissue Processing Engineer to support the development and optimization of tissue processing techniques for implantable medical devices. This contract-to-hire role focuses on hands-on process development, pilot manufacturing, and cross-functional collaboration to ensure high-quality, scalable production of tissue-based products.

Key Responsibilities:

• Develop and validate tissue processing methods using animal-derived tissue.

• Evaluate and select chemicals and reagents in line with regulatory and biocompatibility standards.

• Support pilot and manufacturing operations, adhering to GMP and ISO standards.

• Conduct risk assessments and process validations (IQ/OQ/PQ).

• Lead process improvements and support investigations and CAPAs.

• Stay current on tissue processing trends and regulatory requirements.

• (Preferred) Apply expertise in cardiovascular tissue valve processing.

Qualifications:

• Bachelor’s or Master’s in Biomedical/Chemical Engineering or related field.

• 3–5 years of experience in tissue processing for medical devices or biotech.

• Knowledge of tissue processing chemicals (e.g., glutaraldehyde, ethanol).

• Experience with tissue sterilization, preservation, and pilot-scale production.

• Familiarity with FDA, ISO 13485, and GMP standards.

• Strong problem-solving, technical writing, and team collaboration skills.

• Preferred: Experience with cardiovascular tissue valve processing.