Mechanical Engineer


Position: Mechanical Engineer
Location: Bothell, Washington
Duties: Design mechanical parts and assemblies for consumer or medical device products. Provide quality products and/or services to clients. Perform engineering analyses such as tolerance, stress/strain, and thermal to ensure products meet requirements and specifications. Develop 3D model parts and assemblies using Computer Aided Design (CAD) software (SolidWorks, Creo). Prototype parts or fixtures using machine shop equipment (mill, lathe, band saw, drill press) and rapid manufacturing methods (3D printing). Author test plans, execute tests, and author reports for prototype and final product verification and validation. Develop component and subsystem specifications that ensure final product will meet system-level requirements. Lead and formally document concept generation, design alternatives selection, and design reviews. Work with third party contract manufacturing companies to procure quality parts including validating manufacturing processes and inspection methods. Ensure compliance with industry standards and regulations (ISO 13485, IEC 60601-1, and FDA design control and current Good Manufacturing Practice). Perform investigation and resolution of failures / issues / defects. Implement design changes during product development and/or post-market phases, including design, verification & validation, transfer to manufacturing, and/or process validation. Either manage project and execute technical work, or work with a project manager to forecast schedule and budget, and report status to clients.
Local day travel within metro area may be required based on assignment.

Education: Bachelor’s degree in Mechanical Engineering or related field (foreign equivalent acceptable); and

Experience: 3 years’ post-Bachelor’s experience as a Mechanical Engineer, Staff Mechanical Engineer, or similar position.

Academic or employment experience in each of the following:
1) designing molded parts;
2) performing engineering analyses including tolerance, stress/strain, and thermal;
3) working with CAD tools, specifically SolidWorks or Creo;
4) fabricating parts using machine shop equipment and additive manufacturing methods;
3 years’ employment experience in each of the following:
5) hands-on engineering experience developing and manufacturing products in FDA regulated life
sciences industry (Medical Device, Pharma, or Biotech);
6) leading and/or supporting the execution of technical projects for at least six (6) clients in a consultant
7) working within Quality Management Systems for medical products to ensure compliance with ISO and
FDA regulations, including at least 1 year with ISO 13485 and 21 CFR Part 820;
2 years’ employment experience in each of the following:
8) authoring test plans, protocols, reports, and deviations for medical products;
9) working within Quality Management System software to create and update controlled documents
including design history file, device master record, and quality system record;
1 year employment experience in each of the following:
10) planning and executing transfer to manufacturing, verification, and validation for medical products
and manufacturing processes;
11) developing technical specifications and acceptance criteria including incoming, in-process, and final
product inspection for medical products that are traceable to system-level requirements, including
identification of essential outputs and process control strategy;
12) performing investigation and root cause analysis of failures / issues / defects;
13) performing risk analyses, including Failure Mode and Effects Analysis (FMEA);
14) technical project management including:
a. schedule using MS Project
b. budget and issuing change requests / change orders
c. quality and scope creep
d. regular status reporting to clients and stakeholder
e. work with remote teams

All experience, skills and requirements may be gained concurrently.

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