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 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

Key Areas of Responsibility:

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:

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.