R&D Engineer II - Valve at 4 C Medical Technologies

Maple Grove, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

21 Aug, 26

Salary

110000.0

Posted On

23 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Product Development, Heart Valve Design, Test Method Validation, Hydrodynamic Testing, Accelerated Wear Testing, Tissue Mechanical Testing, Data Analysis, Regulatory Compliance, Project Management, SolidWorks, Minitab, Design Control, Prototyping, Verification and Validation, Root Cause Investigation, Technology Transfer

Industry

Biotechnology

Description

Description 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. 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. HOW YOU WILL CONTIRBUTE (Overview & Key Responsibilities) Product Development: 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. Technical Expertise: 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. Testing & Data Analysis: 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. Regulatory Compliance: 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. Quality Assurance: 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. Project Management: 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. 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) 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. WHAT WILL SET YOU APART (Competencies) 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

The role focuses on the design, development, and testing of transcatheter mitral valve replacement (TMVR) systems. Key duties include leading test method validation, executing critical implant testing, and collaborating with manufacturing and regulatory teams for product scale-up.