Address
Form of workTioga Cardiovascular, a Shifamed Portfolio Company, is developing a minimally invasive, transcatheter mitral valve replacement therapy that is both easier to use and implantable in a higher percentage of patients with mitral regurgitation. To learn more about Tioga Cardiovascular, please visit www.tiogacardiovascular.com.
ABOUT SHIFAMED
Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.
Description
As a Principal R&D Engineer on the Tioga Medical team, you will serve as the Technical Lead of all things Nitinol, owning the design, process development, and V&V testing of Tioga’s TMVR implant. Leveraging Tioga’s vertically integrated Nitinol production facility, you will be in a position to rapidly realize concepts and deliver a best-in-class TMVR product to patients.
Responsibilities, Skills & Hands-On Experience
- Expertise in design and development of medical devices; Class III cardiovascular experience preferred.
- Own TMVR nitinol frame design; leveraging in house manufacturing processes including laser cutting, shape-setting, media-blasting, laser welding, etching, and electropolishing.
- Develop and validate FEA stress/strain models of cardiovascular implants; Abaqus preferred.
- Expertise in designing and making test/process fixtures and equipment using hands on prototyping skills.
- Experience using software to automate inspections and characterize images.
- Substantial experience in CAD design and documentation software; SolidWorks preferred.
- Experience in planning and executing V&V testing; Nitinol fatigue experience preferred.
- Expertise in writing test protocols, test reports, design documentation, and contributing to design reviews.
- Strong cross functional communication skills, able to explain complex topics to a variety of stakeholders.
- Partner with operations to optimize Nitinol manufacturing, validate processes, and scale output.
- Able to mentor team members and work both independently and in a project team setting.
- Knowledge of statistical methods and applications for data driven decision making.
- Select and manage suppliers, including understanding of capabilities, materials, and fabrication processes.
- Supporting regulatory filings including writing technical sections and providing general technical input.
- Project manage and support external consulting firms and/or contract manufacturers as required.
Education & Work Experience
- Bachelor's Degree or higher in Mechanical/Materials/Aerospace Engineering
- At least 10 years of experience, primarily in the medical device industry.
- Track record of bringing Cardiovascular implants to a clinical trial or to market from an early stage.
- Previous experience working with pre-clinical testing.
Our salary ranges are calculated by role and level. Your position within that range will be determined by your job-related knowledge, skills, experience, relevant education, and training/certifications. In addition to those factors, we also examine internal equity as well as consider current market rate, and title may be assessed one level lower or higher accordingly. After you join the company your performance, contributions, and results along with business and organizational needs will affect your base salary. The base salary range for this full-time position is between $90,000 to $180,000 + equity + benefits.
NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to hr@shifamed.com.
