Research and Development Engineer at 4 C Medical Technologies

Maple Grove, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

03 Sep, 26

Salary

130000.0

Posted On

06 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

SolidWorks, ProE, Fluoroscopy, Echocardiography, Materialise, Mimics, Human Factors Engineering, Minitab, Cardiovascular Anatomy, Data Management, Systems Thinking, Technical Documentation, Risk Assessment, Test Method Validation, Analytical Ability, Cross-functional Collaboration

Industry

Biotechnology

Description

Description THE OPPORTUNITY: 4C Medical Technologies, Inc. is engineering a first-in-class Transcatheter Mitral Valve Replacement (TMVR) system to redefine care for patients with mitral regurgitation. We seek a highly motivated R&D Engineer to focus on gathering clinical feedback in order to troubleshoot issues and improve the efficiency and effectiveness of our therapy. This position combines engineering expertise with clinical insight to translate medical needs into product design requirements. The ideal candidate will bridge the gap between engineering and clinical operations, to ensure design intent aligns with procedural performance and patient outcomes. At 4C Medical, the distance between your insight and its impact on a patient is short. You want it that way. CORE RESPONSBILTIES: Analyze product performance data as well as clinical and anatomical data relevant to procedural parameters with the goal of continuous improvements in procedural steps and product design optimizations. Lead gathering and evaluation of case findings with cross-functional teams (e.g., clinical, therapy development, regulatory, etc.) to ensure detailed review of procedures, device performance and other analyses. Facilitate the incorporation of case learnings to procedural documentation and training materials. Conduct pre-clinical, simulated-use and usability testing to assess device performance and user interaction. Lead Human Factors Engineering (HFE) efforts. Maintain familiarity with competitive technologies and clinical literature in structural heart interventions. Translate clinical and physician feedback into actionable product requirements and engineering specifications. Support test method development, fixture design, test method validation and execution of critical testing. Actively participate in the preparation of technical documentation, risk assessments, and regulatory submissions. Travel up to 10% (pre-clinical and clinical site support) Requirements EDUCATION & EXPERIENCE: B.S. in Biomedical, Mechanical, or related Engineering field (M.S./Ph.D. preferred) TECHNICAL SKILLS: CAD proficiency (SolidWorks/ProE) Anatomical imaging (fluoroscopy, echocardiography) modeling (Materialise, Mimics) Systems and Human Factors Engineering (HFE) Statistical tools (Minitab) Data management Working understanding of cardiovascular anatomy, physiology, and transcatheter device procedures SOFT SKILLSs: Strong analytical ability driven by an analytical mindset, systems thinking and attention to procedural detail Strong verbal and written communication skills Ability to effectively collaborate across multidisciplinary environments Comfortable bridging R&D and clinical worlds. Adaptable and collaborative in fast-paced, iterative environments. Committed to innovation and patient-centered device development.

Responsibilities

The role focuses on analyzing clinical and anatomical data to optimize product design and procedural steps for a TMVR system. The engineer will lead Human Factors Engineering efforts and translate physician feedback into actionable engineering specifications.