Sr. R&D Engineer - Maple Grove - JCW Group

    JCW Group
    JCW Group Maple Grove

    1 week ago

    Description

    Posted: 03/02/2026 Location: Maple Grove, Minnesota, United States Salary: $ $130000 Job type: Permanent
    Senior R&D Engineer - Medical Devices
    Role Overview
    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.
    Key Responsibilities

    • 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.
    Required Qualifications
    • 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.
    Preferred Qualifications
    • 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.

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