R&D Engineer II - Valve

4 C Medical Technologies•Maple Grove, MN

49m•$85,000 - $110,000

About The Position

4C is a structural heart medical device company developing an innovative transcatheter mitral valve replacement (TMVR) system to advance treatment for mitral regurgitation. As an R&D Engineer II specializing 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 the ability to solve complex problems. The successful candidate will support development projects, testing and continuous improvement efforts.

Requirements

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related technical field; Master’s preferred.
Minimum of 2 years of experience in product development and engineering. Preferably with experience in the medical device industry, specifically interventional or implantable devices.
Experience designing, prototyping and testing complex medical devices.
Demonstrated experience solving complex technical problems and implementing solutions.
Experience with design change management and technology transfer in a highly regulated industry.
Skilled in research, design, prototyping, and testing of complex devices. Experience in medical device, specifically structural heart, highly preferred.
Ability to develop, validate and execute test methods. Ability to conduct hands-on verification and validation testing.
Working knowledge of cardiovascular anatomy and physiology.
Deep understanding of engineering principles, mechanics, material science, fluid dynamic, and med device manufacturing (e.g. injection molding, extrusion, machining, 3D printing, laser processing, etc.).
Knowledge of design control, regulatory standards, quality systems risk management (e.g., ISO 13485, FDA QSR, IEC 60601).
Proficient with CAD tools (e.g., SolidWorks), developing drawings, and physical prototyping.
Skilled in data analysis and analytical tools such as Minitab (ANOVA, t-test, capability analysis, Gage R&R)
Ability to clearly present technical information to non-technical stakeholders
Excellent interpersonal, verbal, and written communication skills.
Demonstrated ability to collaborate with cross-functional teams and manage complex projects with internal and external stakeholders.

Responsibilities

Support design and development of novel heart valve technologies, with a focus on valve design.
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, heart valve technologies and relevant medical device regulations.
Troubleshoot technical challenges, support root cause investigations and participate in technical design reviews.
Plan, execute, and document engineering evaluations, and bench tests.
Lead verification and validation activities in preparation for regulatory submissions.
Analyze data, summarize findings, and present technical conclusions to the team to drive data-based decisions.
Work closely with the Regulatory Affairs team to ensure heart valve design and development efforts comply with applicable regulatory standards and requirements.
Collaborate in preparing regulatory submissions.
Collaborate with the Quality Assurance team to maintain robust quality control and documentation for heart valve design, manufacturing and testing.
Implement and oversee test methods, protocols and reports to validate the performance and safety of heart valve products.
Ability to work independently on complex tasks. Manage timeline, prioritize multiple tasks, and drive completion of deliverables while collaborating 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 management and relevant stakeholders.