Sr. R&D Engineer

Custom Search Inc.; Maple Grove (MN); Presencial; USD 110.000 - 150.000; Jornada completa

Descripción de la vacante

Custom Search Inc. partners with a leading structural heart medical device company to advance a next-generation transcatheter mitral valve replacement (TMVR) system.

The Senior R&D Engineer will design and develop transcatheter delivery systems, catheters, and fixtures, translating clinical needs into engineering solutions and supporting verification, validation, and design transfer. This highly hands-on role requires CAD proficiency (SolidWorks, Creo/ProEngineer, AutoCAD), prototype

Formación

• B.S. in Mechanical Engineering or related field.
• 5+ years of engineering experience with 3+ years in medical device product development.
• Experience with catheter-based delivery systems.
• Strong mechanical design, engineering analysis, testing and problem-solving skills.
• Experience with CAD applications such as SolidWorks, Creo/ProEngineer, or AutoCAD.
• Experience taking medical devices from concept through design transfer and commercialization.

Responsabilidades

• Design and develop transcatheter delivery systems, catheter assemblies, mechanical components, deployment mechanisms, prototypes, and fixtures.
• Translate physician feedback, clinical needs, and product requirements into practical engineering solutions.
• Use CAD/SolidWorks to support mechanical design, tolerance analysis, component specifications, material selection, and engineering drawings.
• Develop prototypes and perform bench testing to evaluate designs and drive iterative improvements.
• Address technical challenges involving navigation, tracking, positioning, deployment, flexibility, pushability, torque, and overall system performance.
• Support catheter construction and manufacturing processes including extrusion, hypotubes, braiding/coiling, reflow, bonding, machining, molding, and adhesives.
• Lead and support test method development, verification and validation, data analysis, and technical reporting.
• Participate in design reviews, FMEAs, risk assessments, and root-cause investigations.
• Support preclinical testing, physician evaluations, clinical builds, and device investigations.
• Partner closely with R&D, Manufacturing, Quality, Clinical, physicians, suppliers, and other cross-functional teams.
• Support design transfer, manufacturing scale-up, supplier qualification, tooling, fixtures, and production activities.

Conocimientos

Mechanical design

Engineering analysis

Testing

Problem-solving

Cross-functional collaboration

Medical device development

CAD applications

Educación

Bachelor's degree in Mechanical Engineering

Herramientas

SolidWorks

Creo/ProEngineer

AutoCAD

Descripción del empleo

We’ve partnered with an innovative structural heart medical device company developing a next-generation transcatheter mitral valve replacement (TMVR) system for the treatment of mitral regurgitation.

They are adding a Senior R&D Engineer to join their team and support the design and development of transcatheter delivery systems from concept through verification, validation, design transfer, and commercialization.

This is a highly hands-on engineering role for someone who enjoys solving complex technical problems and wants to make a meaningful impact within a growing structural heart organization.

Your role with the company:

• Design and develop transcatheter delivery systems, catheter assemblies, mechanical components, deployment mechanisms, prototypes, and fixtures

• Translate physician feedback, clinical needs, and product requirements into practical engineering solutions

• Use CAD/SolidWorks to support mechanical design, tolerance analysis, component specifications, material selection, and engineering drawings

• Develop prototypes and perform bench testing to evaluate designs and drive iterative improvements

• Address technical challenges involving navigation, tracking, positioning, deployment, flexibility, pushability, torque, and overall system performance

• Support catheter construction and manufacturing processes including extrusion, hypotubes, braiding/coiling, reflow, bonding, machining, molding, and adhesives

• Lead and support test method development, verification and validation, data analysis, and technical reporting

• Participate in design reviews, FMEAs, risk assessments, and root-cause investigations

• Support preclinical testing, physician evaluations, clinical builds, and device investigations

• Partner closely with R&D, Manufacturing, Quality, Clinical, physicians, suppliers, and other cross-functional teams

• Support design transfer, manufacturing scale-up, supplier qualification, tooling, fixtures, and production activities

Desired Profile:

• B.S. in Mechanical Engineering or a related engineering discipline

• 5+ years of engineering experience with 3+ years in medical device product development

• Experience with catheter-based delivery systems

• Strong mechanical design, engineering analysis, testing, and problem-solving skills

• Experience with CAD applications such as SolidWorks, Creo/ProEngineer, or AutoCAD

• Experience with test method development and design controls

• Experience taking medical devices from concept through design transfer and commercialization is highly desirable

• Ability to work independently while collaborating effectively across technical and clinical teams