Process Engineer

Tissue Processing Engineer

Job Summary:

We are seeking a skilled and experienced Tissue Processing Engineer to join our team.

Key Responsibilities:

Develop, optimize, and validate tissue processing procedures using animal-derived tissues for implantable medical devices.

Select and evaluate tissue processing chemicals and reagents, ensuring alignment with biocompatibility, sterilization, and regulatory standards.

Collaborate with cross-functional teams (R&D, Quality, Regulatory, Manufacturing) to develop scalable processes for pilot and full-scale manufacturing.

Lead or support pilot line and manufacturing line operations, ensuring robust process control and adherence to GMP and ISO standards.

Perform and document risk assessments, process validations (IQ/OQ/PQ), and implement process improvements to enhance product consistency and reduce variability.

Provide technical support for investigations, CAPAs, and root cause analysis related to tissue quality or processing issues.

Maintain current knowledge of industry trends, regulatory requirements, and best practices in tissue processing and preservation.

(Preferred) Apply specialized knowledge in cardiovascular tissue valve processing, including decellularization, sterilization, and preservation techniques.

Qualifications:

Bachelor’s or master’s degree in biomedical engineering, Chemical Engineering, Biological Sciences, or a related field.

Demonstrated experience with common tissue processing chemicals such as fixatives, detergents, and sterilants (e.g., glutaraldehyde, ethanol, peracetic acid).

Direct experience in pilot or manufacturing line setup and operation for tissue-based products.

Working knowledge of FDA regulations, ISO 13485, and GMP practices.

Excellent problem-solving, technical writing, and cross-functional collaboration skills.

Nice to have: Experience with cardiovascular tissue valve processing (e.g., porcine or bovine valves), including decellularization and preservation technologies.