Mechanical Design Engineer (Medical??????? Device)

Mechanical Design Engineer - Vascular Devices)

• Location: 100% ONSITE - Tempe, Arizona (85283)
• Type: W2 contract (NO C2C OR THIRD PARTY will be considered)
• Pay Rate: Negotiable depending on direct related experience UP to $48 - $53/hour
• Duration: 9 months contract
• Work Authorization: Must be currently located and authorized to work in the United States without CURRENT Visa transfer or sponsorship requirements.

KEY AREAS OF RESPONSIBILITY: What you will do:

Technical Responsibilities:

• Research, design, develop, modify, and verify components and systems for medical devices with minimal supervision.
• Translate user needs to design inputs/ specifications and produce system-level designs.
• Develop and analyze solutions, prototyping one or more options to provide proof of concept.
• Apply fundamental and some advanced concepts, practices and procedures for problem solving.
• Support problem solving, root cause analysis, identify potential solutions, and evaluate them against requirements.
• Develop bench testing methods, conduct measurement system analysis, and develop DOE.
• Conduct research and studies to support product design.

Business Responsibilities:

• Demonstrate advanced understanding of customer needs and design inputs.
• Demonstrate proficiency with product's intended use and clinical procedures.
• Learn how the financial models are constructed
• Support Voice of Customer sessions internally and with clinicians to develop an understanding of customer needs
• Apply understanding of customer needs to development of robust and appropriate design inputs.
• Understand the product's intended use and clinical procedures.
• Apply understanding of the impact of design decisions on production metrics (COGS, yield, etc.).

Med Device Compliance:

• Follow fundamental industry standards, design requirements and test strategies which apply to regulatory requirements.
• Independently create or refine engineering documentation, such as the Design History file.
• Follow R&D procedures like design controls and risk management, per the Quality Management System.

PREFERRED QUALIFICATIONS: What you will need (strongly desired):

Technical Skills:

• Vascular device engineering preferred
• Technical ability to develop and optimize designs for medical device assemblies, incorporating DFM principles and clinical feedback and knowledge.
• Ability to communicate basic plans and technical information to team members, leaders, and project managers
• Technical knowledge in creating product test fixtures and developing test methods for verification and validation activities
• Fundamental knowledge and understanding of engineering practices, tools, and design principles within a regulated environment.
• Demonstrated ability to influence and drive results through others.

Work Authorization: Must be currently located and authorized to work in the United States without current transfer or future sponsorship requirements. - No C2C or third-party candidates. ~

*** Kelly does not expense relocation/interview costs. ***

Important information: To be immediately considered, please send an updated version of your resume to Deas172@kellyservices.com.

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