Principal R&D Engineer

PRINCIPAL R&D ENGINEER

If you're energized by collaboration, driven by purpose, and ready to take ownership of your impact, we offer 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.

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.

Product Development:

- 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.

Technical Expertise:

- 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.

Testing & Data Analysis:

- 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.

Regulatory Compliance:

- 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.

Quality Assurance:

- 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.

Project Management:

- 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.

Skills

Medical device, Design assurance, Iso 13485, Design control, Risk management, Design validation, Validation, Quality engineering, New product development, Process development, Mechanical engineering, R&d

Top Skills Details

Medical device,Design assurance,Iso 13485,Design control,Risk management,Design validation,Validation

Additional

Skills & Qualifications

- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related technical field;
Master's or Ph.D. preferred.

- Minimum of 5 years of progressive experience in product development and engineering, with at least 3 years in the medical device industry, preferably in interventional or implantable devices.

- Experience designing, prototyping and testing complex medical devices.

- Demonstrated experience solving complex technical problems, leading technical projects and implementing solutions.

- Experience with design change management and technology transfer in the med device space.

- Proven expertise in research, design, prototyping, and testing of interventional medical devices. Expertise in structural heart valve development highly preferred.

- Working knowledge of cardiovascular anatomy and physiology.

- Strong understanding of materials science, biomechanics, and medical device manufacturing processes (e.g., nitinol, tissue, extrusion, laser processing, etc.).

- Knowledge of regulatory standards and quality systems (e.g., ISO 13485, FDA QSR, IEC 60601).

- Proficient in CAD tools (e.g., Solid Works) and design verification tools (e.g., FEA, tolerance analysis). Expertise in data analysis and analytical tools such as Minitab.

- Excellent interpersonal, verbal, and written communication skills.

- Demonstrated ability to work with cross-functional teams and manage complex projects with internal and external stakeholders.

- Ability to clearly present technical information to…