Location: White Bear Lake, MN
Salary: $100,000.00 USD Annually - $150,000.00 USD Annually
Description:
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 production
Qualifications:
- 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, MN
Apply or reach out directly: jtooker@judge.com
This job and many more are available through The Judge Group. Find us on the web at www.judge.com
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