Overview:

This is an opportunity to join a medical device company developing an innovative transcatheter mitral valve replacement (TMVR) system to advance treatment for mitral regurgitation. As a Senior R&D Engineer specializing in heart valves, you will partner with a high-performing, cross-functional team to design and develop the TMVR system with a focus on 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.

Responsibilities:

1. 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, with a focus 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.

Qualifications:

Education

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

Experience

• 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 medical device space.

Knowledge, Skills and Abilities

• 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).
• Knowledge of regulatory standards and quality systems (e.g., ISO 13485, FDA QSR, IEC 60601).
• Proficient in CAD tools (e.g., SolidWorks) 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 non-technical stakeholders and executive leadership.
• Proven ability to foster collaboration across R&D, clinical, regulatory, quality, and manufacturing functions.