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Electronics Quality Engineer

Company: NuVasive, Inc.
Location: Broomfield
Posted on: September 16, 2021

Job Description:

An employer in the Denver, CO area is looking for an Electrical Quality Engineer. Designs, implements and maintains quality design protocols and methods for electromechanical/robotics products. **The ideal candidate will have a strong background in reviewing protocols and design controls. The candidate will need two have a an understanding in ISO 13485, ISO 14971 (Risk management), 60601, and 6203 regulations. It is a big plus if they have experience working on image capturing medical devices. *The candidate will need to provide quality support on design changes to existing products and the entirety of moderately complex electromechanical projects requiring familiarity with and understanding of the required design control documentation. *Reviews product and process changes for qualification and validation requirements, and assists in change implementations. Provides technical input on risk management and ensures successful implementation of the risk management program for both safety and security product elements, as applicable. Implements systems to ensure timely quality inspections for incoming materials, components or finished goods products, and performs inspections as needed and conducts investigations on complaints or audit issues as quality system feedback is provided.

- Experience working in Quality Medical Device on Image capturing electromechanical products

- Verification and Validation Experience (V&V) for quality engineering

- Master's degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Quality Engineering, or a related field.

- Experience doing Quality Engineering for Robotics products

- Experience doing Quality Engineering for Surgical Products
- Bachelor's degree required in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Quality Engineering, or a related field.

- 2-5 years minimum of experience working in a regulated environment (Med Device or Aerospace)

- Experience working on reviewing protocols and **design controls** for Electromechanical products.

- Experience working with ISO 13485, ISO 14971 (Risk management), IEC 60601, and 6203 regulations.

- Familiar with design history files and the documentation of user needs, subsequent verification and validation tests as well as risk analysis to support the launch of medical devices.

Keywords: NuVasive, Inc., Broomfield , Electronics Quality Engineer, Other , Broomfield, Colorado

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