Principal Technical Engineer

2 weeks ago

Maple Grove, United States Hiring Now! Full time

Our client, a medical device manufacturing company located in White Bear Lake, is currently seeking a Principal Technical Engineer. In this position, your primary responsibility will be designing electro-mechanical systems and creating system architecture while producing necessary documentation following established quality system procedures. A crucial part of this role involves working with teams of experts from various fields to meet the needs of both products and projects, collaborating with engineers from different industries.Responsibilities:Develop internal requirement sets and aid customers in formulating user requirements when necessary.Assist in creating, reviewing, and documenting risk analyses.Contribute to risk management planning and reporting.Potentially participate in developing Hazard Analysis.Ensure adherence to product verification, validation, and traceability for all requirements.Coordinate and facilitate interdisciplinary technical discussions within project teams.Document and coordinate system-level analysis encompassing system modeling, algorithm development, simulations, and system architecture.Act as the primary technical contact for customers during projects.Versed in full product development process - concept through productionQualifications:Bachelor's degree in Computer Science or an Engineering discipline.Master's Degree in Engineering is advantageous.Five or more years of experience, preferably in the medical device sector, in systems engineering.Knowledge of modeling tools (Matlab, Simulink, etc.) is a plus.Familiarity with FDA 510(k), PMA, and De Novo pre-market submission processes is advantageous.Experience in developing Class II and III medical devices is beneficial.**This is a full time, direct hire role. No relocation is provided so be in a commutable distance to White Bear Lake, MNApply or reach out directly:

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