The Senior R&D Engineer leads and supports the development of innovative medical devices from early concept through commercialization. This role combines hands-on engineering execution with technical leadership, cross-functional collaboration, and mentorship to deliver high-quality, compliant products that meet user, patient, and clinical needs.
Lead product development activities from concept generation and design through verification, validation, and commercialization in compliance with Quality System and Design Control requirements.
Serve as technical lead or senior contributor on cross-functional development teams, driving complex projects across the full product lifecycle.
Conceptualize, design, build, and evaluate prototype devices and assemblies to assess feasibility, performance, and risk.
Translate user, patient, and clinical needs into robust design inputs, specifications, and test methods, ensuring traceability and regulatory compliance.
Develop and execute robust test methods and design fixtures to evaluate materials, components, and device designs against defined requirements.
Drive technical problem-solving for complex design, materials, and process challenges, recommending and implementing effective solutions.
Communicate technical status, risks, and deliverables across engineering, quality, regulatory, manufacturing, and program teams.
Interface professionally with physicians, customers, and medical personnel while maintaining confidentiality and protecting intellectual property.
Author and review engineering protocols, reports, and technical documentation using basic statistical analysis.
Partner with external suppliers to source, develop, and refine components, materials, and equipment.
Lead or support verification and validation activities through regulatory clearance and design transfer, including hands-on device builds.
Contribute to product line extensions, design improvements, and continuous improvement initiatives.
Mentor junior engineers and provide technical guidance to strengthen R&D capabilities and best practices.
Bachelor’s degree in Engineering or a related technical field with 5+ years of relevant experience (or 8+ years without a degree).
Demonstrated ability to independently lead technical workstreams and solve complex engineering problems.
Strong written and verbal communication skills with the ability to influence across functions.
Proven ability to manage priorities, timelines, and deliverables with minimal supervision.
Strong interpersonal and organizational skills with a collaborative mindset.
Working knowledge of statistical techniques and data-driven decision making.
Proficiency with CAD and engineering tools (SolidWorks, spreadsheets, word processing, databases).
Hands-on experience with common lab equipment and testing practices (e.g., calipers, micrometers, tensile and pressure testing, vision systems).
Knowledge of applicable U.S. and international standards.
Experience with catheter design and manufacturing processes, including extrusion, injection molding, machining, fixtures and tooling, adhesive and thermal bonding.
Strong understanding of medical device materials, processes, design controls, test methods, and metrology.
Working knowledge of medical device quality systems and regulatory requirements.
CAD expertise using SolidWorks.
Ability to translate clinical and user requirements into detailed, actionable technical specifications.
Experience successfully taking products from development through commercial launch.
