Job description

Job Title: Mechanical Engineer/Electro Mechanical Engineer

Location: Bothell, WA

Job Description:

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.

Qualification:

· BE/B Tech Electrical Engineering or Equivalent

Skill Key Word:

Experience: Mechanical Design, Risk management, FMEA, Understanding of electromechanical systems, medical device knowledge, testing.

Job Type: Full-time

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Bothell, WA 98011: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location

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