Sr. or Principal R&D Engineer; DOQ

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.

We are looking for a motivated Senior R&D Engineer with a specialization in heart valves. You will partner with a high-performing, cross-functional team to design and develop our TMVR system with a focus on our valve technologies. This role requires strong technical expertise and a strong understanding of the clinical and regulatory framework for heart valve systems. The successful candidate will drive development projects, support key technical decisions and lead continuous improvement efforts.

• Drive design and development of novel heart valve technologies, with a focus on valve design.
• Understand customer needs and contribute to the development of product requirements.
• Lead test method development, fixture design, test method validation and execution of critical testing. Focused on implant testing such as hydrodynamic testing, accelerated wear testing and tissue mechanical testing.
• Work with Manufacturing teams to ensure seamless technology transfer, production scale-up and continuous improvement efforts.

• Develop and maintain a deep understanding of cardiovascular anatomy and physiology, the latest advancements in heart valve technologies and relevant medical device regulations.
• Troubleshoot technical challenges, conduct root cause investigations and participate in technical design reviews.

• Plan, execute, and document engineering evaluations, bench tests, and preclinical studies.
• Lead verification and validation activities in preparation for regulatory submissions.
• Analyze data, summarize findings, and present technical conclusions to the team and leadership to drive data-based decisions.

• Work closely with the Regulatory Affairs team to ensure all heart valve designs and developments comply with applicable regulatory standards and requirements.
• Collaborate in preparing regulatory submissions.

• Collaborate with the Quality Assurance team to establish and maintain robust quality control processes for heart valve manufacturing and testing.
• Implement and oversee test methods, protocols and reports to validate the performance and safety of heart valve products.

• Develop and manage project plans, while working with internal and external stakeholders to ensure that milestones and deadlines are met.
• Identify and mitigate risks associated with project timelines and deliverables.
• Communicate progress and challenges effectively to senior management and relevant stakeholders.
• Collaborate with cross-functional teams, including R&D, Quality Assurance, Regulatory Affairs, and Manufacturing, to ensure alignment with project goals and timelines, encouraging open communication and knowledge sharing.

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,…