Senior Design Assurance Engineer

• Applies design engineering tools and concepts such as DFMEA, Design Verification & Validation, Benchmarking, and Design Transfer.
• Utilizes systematic problem-solving methods (e.g., DMAIC, Root Cause Analysis, 5 Whys) to identify and resolve quality issues, including CAPA activities.
• Reviews and approves quality records, including specifications and test documentation.
• Leads or contributes to solving complex technical problems through structured methodologies.
• Builds and supports cross-functional team collaboration, offering strategic guidance and resolving technical challenges across sites.
• Drives continuous improvement initiatives within local and divisional Design Assurance teams.
• Promotes a diverse and inclusive work environment and ensures adherence to quality policies, prioritizing patient safety and product quality.

• Bachelor's degree in engineering or related field with 5+ years of experience, preferably in the medical device industry.
• Strong knowledge of Quality System Regulations, ISO 13485, ISO 14971, and design controls with a focus on quality and compliance.
• Skilled in technical problem-solving, data analysis, and writing specifications, test protocols, and technical reports.
• Proficient in Microsoft Office and experienced with quality tools like DFMEA, DOE, Root Cause Analysis, and 5 Whys.
• Background in design or process development, including validation activities and continuation engineering.
• Experience with post-market quality efforts including CAPA and returned product analysis, especially with Class III, EME, or AIMD devices.
• Effective communicator with strong multitasking abilities and proven collaboration across cross-functional 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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