Sr. R&D Technician

About the role

We're looking for a Sr. R&D Technician to join our Research & Development team. In this role, you'll independently execute advanced laboratory and product development activities in support of research and development programs.

Responsibilities

• Assemble and refine prototype design concepts with precision and a deep understanding of how each advancement contributes to improved patient outcomes.
• Develop and optimize detailed manufacturing instructions to ensure scalable, repeatable, and high-quality production processes.
• Conduct comprehensive bench testing of designs and subcomponents, proactively identifying opportunities to enhance performance, safety, and reliability.
• Execute and, when appropriate, support development of test protocols in full compliance with regulatory and quality system requirements, demonstrating integrity and accountability in all documentation and practices.
• Perform troubleshooting of test equipment, fixtures, and instrumentation; coordinate calibration activities to maintain data accuracy and laboratory readiness.
• Maintain thorough, accurate, and transparent records of experimental activities, ensuring compliance with design controls, regulatory standards, and internal quality systems.
• Record detailed data, observations, and technical conclusions in laboratory notebooks and electronic systems to support traceability, reproducibility, and audit readiness.
• Analyze test results, summarize findings, and communicate insights clearly to cross-functional stakeholders to drive informed decision-making.
• Partner collaboratively with engineers, quality, regulatory, manufacturing, and physician advisors to advance product development initiatives and solve complex technical challenges.
• Demonstrate curiosity and adaptability by contributing ideas for design improvements, process enhancements, and innovative testing approaches.
• Take initiative in identifying risks, proposing solutions, and supporting continuous improvement efforts with a bold yet thoughtful approach.
• Mentor junior technicians and provide technical guidance to support team development and operational excellence.
• Perform additional responsibilities as assigned, supporting team objectives and advancing departmental and organizational goals.

Qualifications

• Education: High school diploma or general education degree (GED); or equivalent combination of education and experience.
• Experience: Minimum of three (3) years of hands-on laboratory experience in medical device or a related regulated industry; medical device experience preferred.
• Working knowledge of medical device development processes, including documentation and record-keeping within a quality system environment.
• Familiarity with common device materials, including plastics, metals, and adhesives, and their application in product development.
• Proficiency with general laboratory and bench test equipment (e.g., tensile testers, microscopes, measurement tools, and related instrumentation).
• Demonstrated ability to follow test protocols, document results clearly, and support regulatory requirements.

Skills/Competencies

• Technical Expertise: Strong hands-on laboratory and bench testing skills, including prototype assembly, test method execution, data collection, and troubleshooting of laboratory equipment and fixtures.
• Design & Development Support: Working knowledge of product development processes, design controls, and verification/validation activities within a regulated medical device environment.
• Regulatory & Quality Acumen: Solid understanding of documentation practices, traceability requirements, and compliance standards (e.g., FDA Quality System Regulation, ISO 13485) with a commitment to data integrity and audit readiness.
• Analytical Thinking: Ability to interpret test data, identify trends, troubleshoot technical issues, and provide clear, actionable feedback to engineering teams.
• Attention to Detail: High level of accuracy in executing protocols, recording observations, and maintaining laboratory documentation.
• Problem Solving: Proactively identifies technical challenges and contributes practical, well-reasoned solutions that balance innovation with risk mitigation.
• Collaboration: Effectively partners with R&D engineers, Quality, Regulatory, Manufacturing, and cross-functional stakeholders to support project milestones and deliver results.
• Communication Skills: Clearly communicates technical findings verbally and in writing; able to summarize complex data in a concise and understandable format.
• Adaptability & Initiative: Thrives in a fast-paced development environment; demonstrates curiosity, flexibility, and ownership of assigned projects and deliverables.
• Mentorship & Leadership: Provides guidance to junior technicians and contributes to a culture of continuous improvement and operational excellence.