Senior R&D Engineer

About the role

The R&D Engineer leads the development of transcatheter delivery systems and other complex interventional medical devices from initial concept through verification, validation, design transfer, and commercialization. This role translates clinical needs and physician feedback into practical engineering solutions, drives mechanical and catheter design, and ensures products meet rigorous performance, reliability, and regulatory requirements. The position is highly hands-on, combining product development, design controls, manufacturing support, and cross-functional collaboration within a small, innovation-focused team.

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 and detailed design specifications.
• Assist with the design and evaluation of catheter assemblies, mechanical components, deployment mechanisms, prototypes, and fixtures.
• Apply engineering fundamentals to solve challenges related to navigation, tracking, positioning, deployment, flexibility, pushability, torque, and overall system performance.
• Support CAD-based design activities including modeling, tolerance analysis, material selection, component specifications, and creation of engineering drawings.
• Develop prototypes and perform bench testing to evaluate design performance, identify issues, and drive iterative design improvements.
• Gain and apply hands-on experience with catheter construction and manufacturing processes such as extrusion, hypotubes, braiding/coiling, reflow, bonding, machining, molding, and use of adhesives.
• Apply Design for Manufacturing and Assembly (DFMA) principles to improve product manufacturability, robustness, and reliability.
• Support development and maintenance of design control documentation including requirements, design inputs and outputs, specifications, drawings, risk documentation, and other records.
• Lead test method development activities, including design of test protocols, verification and validation testing, data analysis, and preparation of technical reports.
• Participate in design reviews, risk assessments, and root-cause investigations to identify, assess, and resolve technical issues.
• Support design transfer activities, manufacturing scale-up, supplier qualification, and ongoing production support.
• Assist with development of manufacturing specifications, tooling, fixtures, inspection methods, and acceptance criteria to ensure consistent product quality.
• Work closely 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 engineering activities with cross-functional stakeholders to ensure work is completed on time and aligned with project goals.
• Participate in project meetings and clearly communicate status, technical issues, risks, and next steps to engineering and project leadership.
• Provide subsequent product support after commercialization, contributing to continuous improvement and issue resolution.
• Effectively manage large and complex projects, balancing technical depth with timelines and cross-functional coordination.

Requirements

• B.S. in Mechanical Engineering or equivalent technical degree.
• At least 5 years of engineering experience in a relevant field.
• Minimum of 3 years of medical device product development experience within ISO and QSR-regulated environments (preferred but strongly valued).
• Demonstrated experience in medical device development spanning product conception through manufacturing transfer and commercialization.
• Proven experience developing catheter-based, transcatheter, minimally invasive, or other complex interventional medical devices.
• Hands-on experience in vascular R&D development and test method development.
• Strong mechanical engineering skills including engineering analysis, mechanical design, and understanding of mechanical systems and components.
• Proficiency in test development and instrumentation, including designing test methods, executing tests, and interpreting data.
• Experience with design assurance, design controls, risk management, design validation, and quality engineering within medical device environments.
• Experience in new product development and process development for medical devices.
• Knowledge of FDA and ISO guidelines and compliance requirements applicable to medical device design and manufacturing.
• Understanding of regulatory requirements, physiology, and medical or clinical practices relevant to interventional devices.
• Strong problem-solving abilities with a structured, scientific approach to design and investigation.
• Effective interpersonal, oral, and written communication skills with the ability to function independently and collaborate effectively.
• Proficiency with standard computer applications including word processing, database management, spreadsheets, and project management tools.

Qualifications

• Experience with CAD applications such as AutoCAD, SolidWorks, or similar tools.
• Experience with subsequent product support activities, including troubleshooting and continuous improvement post-commercialization.
• Experience in design for manufacturing and assembly (DFMA) for catheter-based and interventional medical devices.
• Ability to effectively manage large projects, including planning, prioritization, and coordination across multiple stakeholders.
• Knowledge of medical device quality engineering practices and design assurance methodologies.
• Familiarity with inspection methods, manufacturing specifications, and acceptance criteria for precision medical components.
• Strong attention to detail and commitment to maintaining product quality, performance, and design intent throughout the product lifecycle.
• Ability to work within a small, culture-oriented team and contribute positively to an innovation-focused environment.

Work environment

This role is based on-site in Maple Grove, MN, within a small, culture-oriented team focused on exciting innovations in transcatheter and interventional medical devices. The environment emphasizes close collaboration with cross-functional partners in engineering, manufacturing, and quality, and offers hands-on access to catheter construction and manufacturing processes, including extrusion, hypotubes, braiding/coiling, reflow, bonding, machining, molding, and adhesive-based assembly. Work is primarily performed in engineering lab and office settings, involving CAD design, bench testing, test method development, and participation in design reviews and project meetings. The team culture supports innovation, technical excellence, and ownership of projects from concept through commercialization.

Pay

The pay range for this position is $100,000.00 - $120,000.00/yr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Benefits

• Medical
• Dental
• Vision
• Flexible Spending Account (FSA)
• Basic Life
• 401(k) Retirement Plan
• Paid Holidays
• PTO
• Maternity/Paternity paid leave

Schedule & location

This is a permanent, fully onsite position based in Maple Grove, MN. The position is anticipated to close on Nov 2, 2026.