Sr. R&D Engineer

WHO WE ARE: If you’re energized by collaboration, driven by purpose, and ready to take ownership of your impact, 4C Medical offers more than just a job—we offer the opportunity to help shape the future of medical innovation. As a growing medical device startup, every team member plays a critical role in advancing technologies that improve patient lives. At 4C Medical, you’ll find an environment where your ideas matter, your growth is prioritized, and your contributions directly influence our success. We’re committed to fostering both personal and professional development in a culture built on accountability, curiosity, and shared purpose. THE OPPORTUNITY 4C is a structural heart medical device company developing an innovative transcatheter mitral valve replacement (TMVR) system to advance treatment for mitral regurgitation. The Sr. R&D Engineer supports the design and development of transcatheter delivery systems from concept through verification, validation, design transfer, and commercialization. This role applies mechanical and catheter engineering principles to develop, prototype, test, and improve device components and systems while translating clinical needs and product requirements into practical engineering solutions. The position works closely with R&D, Manufacturing, Quality, Clinical, physicians, and suppliers to support design controls, technical problem-solving, manufacturing transfer, and successful execution of product development projects. HOW YOU WILL CONTIRBUTE (Overview & Key Responsibilities) Product Development Support the development of transcatheter delivery systems from concept through verification, validation, design transfer, and commercialization. Translate clinical needs, physician feedback, and product requirements into practical engineering solutions. Assist with the design and evaluation of catheter assemblies, mechanical components, deployment mechanisms, prototypes, and fixtures. Apply engineering fundamentals to address challenges involving navigation, tracking, positioning, deployment, flexibility, pushability, torque, and system performance. Mechanical & Catheter Engineering Support CAD design, tolerance analysis, material selection, component specifications, and engineering drawings. Develop prototypes and perform bench testing to evaluate designs and support iterative improvements. Gain hands‑on experience with catheter construction and manufacturing processes, including extrusion, hypotubes, braiding/coiling, reflow, bonding, machining, molding, and adhesives. Apply Design for Manufacturing and Assembly (DFMA) principles to improve product manufacturability and reliability. Design Controls & Testing Support development and maintenance of requirements, design inputs/outputs, specifications, drawings, risk documentation, and other design‑control records. Lead test method development, verification and validation activities, data analysis, and technical reporting. Participate in design reviews, FMEAs, risk assessments, and root‑cause investigations to identify and resolve technical issues. Clinical & Cross‑Functional Collaboration Work with other members of R&D, Manufacturing, Quality, clinical teams, physicians, and suppliers to support product development and address technical challenges. Support preclinical testing, physician evaluations, clinical builds, and device investigations as needed. Communicate engineering findings, test results, risks, and recommendations to project teams and engineering leadership. Manufacturing & Design Transfer Support design transfer, manufacturing scale‑up, supplier qualification, and production activities. Assist with development of manufacturing specifications, tooling, fixtures, inspection methods, and acceptance criteria. Work with cross‑functional teams to resolve manufacturing and supplier issues while maintaining product quality, performance, and design intent. Project Management & Collaboration Support project planning and execution by tracking schedules, milestones, deliverables, risks, and action items . Coordinate with cross‑functional teams to help ensure engineering activities are completed on time and aligned with project goals. Participate in project meetings and communicate status, technical issues, and next steps to engineering and project leadership. WHY JOIN US We recognize that meaningful work is supported by meaningful benefits. That’s why we offer a competitive compensation package along with comprehensive benefits designed to support you and your family’s health, well‑being, and financial future. Our benefits package includes: Medical Dental Vision Flexible Spending Account (FSA) Basic Life 401(k) Retirement Plan Paid Holidays PTO Maternity/Paternity paid leave It is 4C Medical’s policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state or local laws. Requirements WHAT YOU NEED TO SUCCEED (Minimum Qualifications) Requires a B.S. in Mechanical Engineering or equivalent At least 5 years of engineering 3+ Years of medical device product development (ISO/QSR) preferred Experience with subsequent product support is valuable. Experience in vascular R&D development as well as test method development. Medical device development experience covering the range from product conception through manufacturing transfer and commercialization. WHAT WILL SET YOU APART (Competencies) Ability to effectively manage large projects Demonstrated experience developing catheter-based, transcatheter, minimally invasive, or other complex interventional medical devices. Strong mechanical engineering and technical skills are required including: engineering analysis, mechanical design, test and instrumentation. Strong design and scientific methodology is required as well as excellent mechanical and problem‑solving abilities Must have good computer skills that include project management and standard computer applications (word processing, database management, spreadsheets, etc). (Experience with CAD applications (AutoCAD, SolidWorks or ProEngineer) preferred.) Knowledge of regulatory requirements, physiology and medical/clinical practices is also beneficial. Knowledge of FDA, ISO guidelines and compliance requirements are necessary. Effective interpersonal, oral and written communications skills with demonstrated ability to function independently and effectively. #J-18808-Ljbffr