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JOB TITLE: Mechanical Engineer/electro mechanical Engineer

LOCATION: Bothell WA (Onsite)

Duration: Contract

Responsibilities:

• Expert and technical lead with proven experience. Skilled in evaluation, application, synthesis, decision making, and project management. Expert in the Mechanical Engineering Lifecycle with in-depth knowledge of electro mechanical system development.
• Work with the Mechanical team to develop products for the NPI program
• Collaborate across disciplines to achieve project and program goals. These include, but may not be limited to the following:
• Electrical, Software, Systems, Experience Design, Design Transfer, Quality, Regulatory
• Contract design firms, Contract manufacturing firms
• Engineering modeling and analysis of mechanical systems
• Using empirical methods for verifying design performance
• Drawing creation and detailing.
• Prototype and test fixture development
• Meeting program schedule and deliverable goals
• Documenting activities and results
• Contributing to DfM, DfA, DFMEA and usability efforts
• Characterization testing development, execution, and documentation.
• Strong understanding of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001 and ISO 14971
• Excellent written and verbal communication skills in English.. Medical device background preferred. Experience with the following standards is preferred, but not required: ISO 14971, IEC 60601-1, IEC 62304, IEC 60601-2-4, and/or IEC 60601-1-2.