What are the responsibilities and job description for the Staff or Principal Engineer position at Foldax Inc.?
Job Description
Foldax is developing a complete line of surgical and catheter-delivered (TAVR / TMVR) 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) and / or 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 FDA / ISO 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 devices
- B.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 field
- Must have a deep understanding of multi-link designs with Co-Cr and Stainless Steel used with balloons for long-term implantation
- Must be proficient in 3-D modeling software (preferably Solidworks) and have knowledge of and application of drafting practices, GD&T, ASME / ANSI 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 data
- Must 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 detail
- Must have excellent communication skills and ability to work with people at all levels of an organization
- Must have strong failure analysis skills
Nice to Have :
Job Type : Full-time
Pay :
150,000.00 - $200,000.00 per year
Benefits :Work Location : In person
Salary : $150,000 - $200,000
