Engineer, Engineering

Location: Tempe, AZ Salary: $45.00 USD Hourly - $54.00 USD Hourly Description: Our client is currently seeking an Engineer for a 9 month + contract.

Medical, Dental, and Vision Insurance is offered to qualified candidates.

Shift Details:This role will be Mon-Fri 8:00am - 5:00pm. It will be hybrid with the expectation of at least three days on site in Tempe.

Designs, validates and brings new products to market. Specifies precise new product functional requirements; designs, tests and integrates components to produce final designs; and evaluates the design's overall effectiveness, cost, reliability and safety. Designs, develops, executes and evaluates fitness-for-use testing, product specifications and process validation plans; creates and reviews material part specifications and bills of materials. Collaborates with internal manufacturing partners, contract manufacturers, designers and product specialists to optimize designs for manufacturability. Utilizes CAD (Computer Aided Design) or CAE (Computer Aided Engineering) systems to model new designs and produce detailed engineering drawings.

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.

General Responsibilities:

Under minimal supervision, work with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success.

Quickly process and assimilate procedures, policies, processes, systems, and technology required.

Work on complex problems, applying advanced experience and learnings.

Demonstrate ownership and prioritize work with minimal supervision.

Works as key member of the team, collaborating with others and solidifying relationships.

Support multifunctional teams to and execute segments of projects through the design, development, and launch process.

Deliver high quality results with passion, energy and drive to meet business priorities.

Collaborate with cross-functional teams to build partnership to achieve business objectives.

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.

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Contact:

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