Job Description

We are seeking a highly skilled and detail-oriented professional to support the development and optimization of tissue processing methods for implantable medical devices. This role focuses on ensuring the safety, quality, and regulatory compliance of animal-derived tissues used in advanced medical applications.

Key Responsibilities:

• Develop, refine, and validate tissue processing protocols using animal-derived tissues for use in implantable medical devices.
• Select and assess processing reagents and chemicals to ensure compatibility with biocompatibility, sterilization, and regulatory requirements.
• Partner with cross-functional teams—including R&D, Quality, Regulatory Affairs, and Manufacturing—to design and scale processes from pilot to full-scale production.
• Lead or contribute to pilot and production line activities, ensuring process robustness and compliance with GMP, ISO, and other relevant standards.
• Conduct risk assessments and support process validation activities (IQ/OQ/PQ); drive continuous improvement initiatives to enhance product quality and reduce variability.
• Provide technical expertise in resolving tissue-related quality issues, including support for investigations, CAPAs, and root cause analysis.
• Stay current on industry trends, evolving regulations, and best practices in tissue processing and preservation.
• (Preferred) Apply specialized expertise in cardiovascular tissue valve processing, including decellularization, sterilization, and preservation techniques.

Must Haves:

• Bachelor’s degree in Biomedical Engineering, Chemical Engineering, Biological Sciences, or a related field.
• Master's degree is preferred.
• 5- 7 years of hands-on experience in tissue processing within the medical device, biotech, or biopharma industries.
• Experience with cardiovascular tissue valve processing (e.g., porcine or bovine valves), including decellularization and preservation technologies is preferred.
• Proven track record in animal tissue processing process development, including handling, cleaning, preservation, and sterilization.
• Direct experience in pilot or manufacturing line setup and operation for tissue-based products.
• Demonstrated understanding of and ability to work with common tissue processing chemicals such as fixatives, detergents, and sterilants (e.g., glutaraldehyde, ethanol, peracetic acid)
• Working knowledge of FDA regulations, ISO 13485, and GMP practices.
• Excellent problem-solving, technical writing, and cross-functional collaboration skills.

Salary of $100,000 - $140,000 annually + bonus

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