Company Description
PolyVascular is transforming care of children with congenital heart disease by developing an entirely new generation of valves made of medical grade polymer without any animal-derived tissue. Current valves are made from animal-derived tissue, which our immune system targets and destroys, sometimes rapidly, rendering the valve ineffective. Our approach will allow us to deliver these valves in a minimally invasive fashion and reduce the number of open-heart surgeries and improving outcomes for pediatric patients.
Role Description
PolyVascular is seeking candidates for Product Development Engineer or Senior Product Development Engineer (with sufficient experience) to support the development of a novel heart valve for children.
The Product Development Engineer is a full-time, in-person position in Houston, TX, with health benefits. This position will report directly to our Director of R&D.
Responsibilities
- Rapid Onboarding: Quickly learn the product and processes to accelerate development.
- Product Manufacturing: Ensure readiness for and manage product builds.
- Design Verification & Validation: Execute benchtop studies to confirm product performance and compliance to mechanical, durability, and ISO requirements.
- Biocompatibility & Preclinical Testing: Coordinate and interpret results from biocompatibility and animal studies.
- Early Feasibility Study: Assist in planning and preparation for First-in-Human study.
- Regulatory Support: Prepare documentation and assist with FDA interactions to enable first-in-human trials.
- Cross-functional Collaboration: Work closely with leadership and external partners.
Qualifications
- Masters or PhD in engineering (biomedical, mechanical, materials, tissue)
- Medical device development experience under a Quality Management System
- Familiarity with cardiovascular medicine and/or cardiovascular devices
- CAD, computational modeling, and/or simulation skills
- Creative problem solver and/or builder
- Excellent technical writing skills
- Excellent communicator comfortable presenting scientific data in a clear, concise manner to supervisors and team
- Self-motivated, organized, and thorough
- Desire to gain entrepreneurial / industry experience
Additional Information
- Candidates must be legally authorized to work in the US (including OPT)
- Occasional travel is required
- Target start date is in February
