Device Design Engineer

Job Title: Device Design Engineer
Location: Tempe, AZ
Type: Contract
Work Model: Hybrid
Hours: M - F 1st Shift
Security Clearance: (not specified)

Overview
Global Medical Device company looking to hire experienced Device Design Engineer to their growing team. Designs, validates and brings new products to market!

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.
• 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.)
• 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.
• Requirements:
• BS Degree in Engineering required.
• 3-5 years experience required
• 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.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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