Senior Research and Development Engineer

• Develop, validate, and document test methods to support product verification, ensuring accuracy, repeatability, and compliance with standards (ISO 10555, ISO 13485, 21 CFR 820.30, etc.).
• Apply risk-based thinking to identify and control variability in test methods, equipment, and operator performance.
• Collaborate with R&D, Design, Packaging, and Quality teams to align test methods with product design requirements and assess impact of design/process changes.
• Support regulatory compliance and validation activities, maintaining traceability to design specifications, risk analyses, and verification plans.
• Train laboratory staff on validated test methods, equipment calibration, and safety procedures.
• Contribute to risk management documentation (hazard analysis, DFMEA, task analysis, software FMEA) and resolve quality issues using systematic problem-solving.
• Advise management on improvements to quality systems, processes, and products.

• Bachelor's degree in engineering, physics, math, or related science.
• 4+ years' experience in design quality, R&D, or product development within Medtech/regulatory industries.
• Knowledge of ISO 13485, ISO 14971, 21 CFR 820, EU MDR, and industry standards (IEC 60601, IEC 62304).
• Strong analytical, collaborative, and problem-solving skills with ability to navigate ambiguity.
• Willingness to travel (<10%).

• Experience with Single Use Device (SUD) development and Class III medical devices.
• Test method generation and validation (variable and attribute).
• Familiarity with risk management tools such as hazard analysis and FMEA.
• Experience working in highly matrixed, global teams.

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With company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit AdvantageTechnical.com.

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