Staff or Principal Engineer

Job Description :Foldax is developing a complete line of surgical and catheter-delivered (TAVRTMVR) synthetic heart valve products. We are looking for the ideal candidate to join our team. This position will be on a fast-paced, early product development team and the individual who fills it will play a key role in the design, development and testing of valve designs from concept to early clinical feasibility.Design, prototype, and develop innovative designs for use in new products for minimally-invasive surgery to meet customer needs, manufacturability (DFM), cost, quality, and reliability. Perform detailed computational analyses with finite element (FEA) andor fluid dynamics (CFD). Develop design control requirements including the creation of CAD models, assemblies, drawings, detailed specifications, design verification and validation plans, protocols and reports in accordance with established quality systems and FDAISO guidelines. Collaborate closely and effectively with cross-functional departments: Manufacturing, Quality, Regulatory, and Marketing to drive projects to completion within schedule. Manage working partnerships with outside resources contracted for the product development, prototype fabrication, and testing of devices. Identify, collaborate, and manage outside suppliers on material selection, tool design, manufacturing technologies and specifications for components and subassemblies. Generate and document intellectual property (IP). Interact with clinicians to identify unmet user needs to create best-in-class products.Requirements:Hands-on creative R&D engineer with the ability to design and develop complex mechanical devicesB.S. degree in Engineering (Mechanical or Biomedical preferred).Minimum of 5 years experience in cardiac valve R&D, including knowledge of international standards for cardiac valve prosthesis.Experience with CFD, FEA and other simulation techniques (in silico testing digital twin)10+ years of hands-on design and development experience and product release in medical, medical diagnostic, aerospace, automotive, or similarly regulated fieldMust have a deep understanding of multi-link designs with Co-Cr and Stainless Steel used with balloons for long-term implantationMust be proficient in 3-D modeling software (preferably Solidworks) and have knowledge of and application of drafting practices, GD&T, ASMEANSI drawing standards.Must be able to generate innovative concepts, complete design of concept through either SLA or prototype tooling, and test prototype against overall device requirements using valid design of experiments (DOE) and dataMust have strong mechanical aptitude with proven understanding of medical materials and design for manufacturing (DFM).Must be effective working independently as well as in cross-functional teams with strong organization skills and attention to detailMust have excellent communication skills and ability to work with people at all levels of an organizationMust have strong failure analysis skillsNice to Have:Advanced degree in a technical disciplineExperience with a variety of manufacturing methods, including laser processing, electropolishing, heat-treating, injection molding, machining, extrusion, etcThorough understanding of FDA and MDR design control requirements for medical devicesKnowledge of plastics and polymers used in medical disposables and long-term implantsExperience with Matlab, Labview, and other scientific engineering softwareExperience with statistical methods, project management and planningJob Type: Full-timePay: $150,000.00 - $200,000.00 per yearBenefits:401(k)Dental insuranceHealth insurancePaid time offVision insuranceWork Location: In person

Created: 2025-02-21