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Katalyst CRO

R&D Engineer (specialist)

Katalyst CRO, Minneapolis, Minnesota, United States, 55400

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R&D Engineer (specialist)

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Katalyst CRO Get AI-powered advice on this job and more exclusive features. Design and develop test methods to support additional studies. Apply engineering principles to product design analysis and assessment. Produce engineering reports to provide technical explanation to support domestic and international regulatory submissions. Leverage engineering knowledge in conducting complaint evaluations and CAPA investigations to understand potential device failures. Prepare technical product documentation including design history files, drawings, bills of materials, test protocols and reports, engineering change orders, etc. Coordinate and lead competitive testing and aging testing. Interact with physicians to assist with product demonstrations. Optimize and refine existing products. Develop familiarity with endovascular procedures and apply the knowledge to product development and product risk assessment. Provide guidance to technicians and pilot associates. Identify problems and recommend solutions.

Responsibilities

Design and develop test methods to support additional studies. Apply engineering principles to product design analysis and assessment. Produce engineering reports to provide technical explanation to support domestic and international regulatory submissions. Leverage engineering knowledge in conducting complaint evaluations and CAPA investigations to understand potential device failures. Prepare technical product documentation including design history files, drawings, bills of materials, test protocols and reports, engineering change orders, etc. Coordinate and lead competitive testing and aging testing. Interact with physicians to assist with product demonstrations. Optimize and refine existing products. Develop familiarity with endovascular procedures and apply the knowledge to product development and product risk assessment. Provide guidance to technicians and pilot associates. Identify problems and recommend solutions.

Requirements:

Master's degree in science, engineering, or a related field. PMP Certification preferred. Experience in leading process improvement methodologies (e.g., Lean, Hoshin or 6-sigma). Good understanding of the Quality System Regulations (ISO 9001, ISO 13485, 21 CFR Part 803, 806 & 820) and knowledge of medical device process requirements. Seniority level

Seniority level Associate Employment type

Employment type Contract Job function

Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for “Research And Development Engineer” roles.

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