Sr. R&D Engineer

4 C Medical Technologies•Maple Grove, MN

7h•$100,000 - $120,000

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. The Sr. R&D Engineer supports the design and development of transcatheter delivery systems from concept through verification, validation, design transfer, and commercialization. This role applies mechanical and catheter engineering principles to develop, prototype, test, and improve device components and systems while translating clinical needs and product requirements into practical engineering solutions. The position works closely with R&D, Manufacturing, Quality, Clinical, physicians, and suppliers to support design controls, technical problem-solving, manufacturing transfer, and successful execution of product development projects.

Requirements

B.S. in Mechanical Engineering or equivalent
At least 5 years of engineering
3+ Years of medical device product development (ISO/QSR) preferred
Experience with subsequent product support is valuable.
Experience in vascular R&D development as well as test method development.
Medical device development experience covering the range from product conception through manufacturing transfer and commercialization.
Ability to effectively manage large projects
Demonstrated experience developing catheter-based, transcatheter, minimally invasive, or other complex interventional medical devices.
Strong mechanical engineering and technical skills are required including: engineering analysis, mechanical design, test and instrumentation. Strong design and scientific methodology is required as well as excellent mechanical and problem-solving abilities
Must have good computer skills that include project management and standard computer applications (word processing, database management, spreadsheets, etc).
Knowledge of regulatory requirements, physiology and medical/clinical practices is also beneficial. Knowledge of FDA, ISO guidelines and compliance requirements are necessary.
Effective interpersonal, oral and written communications skills with demonstrated ability to function independently and effectively.

Nice To Haves

Experience with CAD applications (AutoCAD, SolidWorks or ProEngineer) preferred.

Responsibilities

Support the development of transcatheter delivery systems from concept through verification, validation, design transfer, and commercialization.
Translate clinical needs, physician feedback, and product requirements into practical engineering solutions.
Assist with the design and evaluation of catheter assemblies, mechanical components, deployment mechanisms, prototypes, and fixtures.
Apply engineering fundamentals to address challenges involving navigation, tracking, positioning, deployment, flexibility, pushability, torque, and system performance.
Support CAD design, tolerance analysis, material selection, component specifications, and engineering drawings.
Develop prototypes and perform bench testing to evaluate designs and support iterative improvements.
Gain hands-on experience with catheter construction and manufacturing processes, including extrusion, hypotubes, braiding/coiling, reflow, bonding, machining, molding, and adhesives.
Apply Design for Manufacturing and Assembly (DFMA) principles to improve product manufacturability and reliability.
Support development and maintenance of requirements, design inputs/outputs, specifications, drawings, risk documentation, and other design-control records.
Lead test method development, verification and validation activities, data analysis, and technical reporting.
Participate in design reviews, FMEAs, risk assessments, and root-cause investigations to identify and resolve technical issues.
Work with other members of R&D, Manufacturing, Quality, clinical teams, physicians, and suppliers to support product development and address technical challenges.
Support preclinical testing, physician evaluations, clinical builds, and device investigations as needed.
Communicate engineering findings, test results, risks, and recommendations to project teams and engineering leadership.
Support design transfer, manufacturing scale-up, supplier qualification, and production activities.
Assist with development of manufacturing specifications, tooling, fixtures, inspection methods, and acceptance criteria.
Work with cross-functional teams to resolve manufacturing and supplier issues while maintaining product quality, performance, and design intent.
Support project planning and execution by tracking schedules, milestones, deliverables, risks, and action items.
Coordinate with cross-functional teams to help ensure engineering activities are completed on time and aligned with project goals.
Participate in project meetings and communicate status, technical issues, and next steps to engineering and project leadership.