Job Type
Full-time
Description
ABOUT 4C MEDICAL TECHNOLOGIES:
We are a small but mighty, well-financed team dedicated to proving the effectiveness of our innovative, life-enhancing, lifesaving therapy. 4C Medical Technologies, Inc., located in Maple Grove, MN, is pioneering the next generation of transcatheter mitral valve replacement (TMVR) technology. Our Alta Valve is currently in the clinical trial phase of FDA approval.
JOB SUMMARY:
We seek a skilled and experienced Tissue Processing Engineer to join our team in developing and optimizing tissue processing techniques for our implantable medical device. The ideal candidate will bring extensive knowledge of tissue processing chemicals, animal tissue handling, and hands-on experience with process development and manufacturing operations. This role is critical in ensuring the consistency, quality, and scalability of our tissue-based medical device products.
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.
- Bachelor's degree in Biomedical Engineering, Chemical Engineering, Biological Sciences, or a related field.
- Related Master's degree preferred.
- Minimum 5 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 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 Description
$100,000 to 140,000 DOQ