Principal R&D Engineer - Yorba Linda, CA

Principal R&D Engineer - (New Product Development) - Infusion Disposables

The Principal R&D Engineer will be working with a dynamic team developing, modifying, implementing and supporting Infusion Disposable products through adherence to established design control processes and good engineering practices. Will solve technical problems using engineering and statistical techniques. Interfaces with customers and suppliers on high-volume disposable medical device design.

Responsibilities:

  • Makes design changes to existing products, ensuring compatibility through appropriate testing. Provides engineering and technical support to production with respect to product specifications and requirements. Guides the successful completion of major programs or projects.
  • Concept Design: Able to generate innovate concepts, complete design of concept, modeling concept through either SLA or prototype tooling, and test prototype against overall device requirements.
  • Design for Manufacturability: Design complex components and assemblies capable of achieving overall device requirements. Perform design verification and transfer to production.
  • Work directly with Clinicians to review product performance.  Gain feedback and implement changes based on clinician feedback. You will be spending time with the customer and the patient. Ability to understand customer requirements and translate those requirements into product designs is required for effective performance in this position.
  • Will work closely with fellow R&D engineers, Customers, Marketing, Sales and Manufacturing regarding New Product Development. The position requires a team-oriented individual with strong interpersonal skills.
  • Ability to manage projects to agreed upon timelines and budgets is required. This position will serve in a results-driven environment

What is expected of you for success in your role? 

  • Experience in product design and development
  • Knowledge of Engineering principles and its application in solving complex problems
  • Demonstrated working knowledge of the design control process as well as completing FMEA and Risk analysis
  • Uses advanced analysis tools and methods to solve complex technical problems (e.g. 3-D Modeling and Design, Computational Fluid Dynamics, and Finite Element Analysis)
  • Working with cross-functional team, establishes customer needs, translates needs into product requirements and verifies design output meets design input
  • Works independently and with teams (technical teams and cross-functional teams)  to create complex designs
  • Evaluates and applies design tradeoffs and constraints for design optimization
  • Independently tests, analyzes and solves technical problems
  • Applies advanced statistical techniques and utilizes design of experiments
  • Assists in due diligence on new technology, license or acquisition opportunities
  • Drives the intellectual property strategy for a product family

Required:

  • Bachelor's degree in Engineering (Mechanical, Plastics, Biomedical) required
  • A minimum of 10+ years related work experience required
  • Previous experience with disposable medical devices in a high-volume manufacturing environment required  
  • Previous experience in a highly regulated environment for Class II disposable medical devices required
  • Very good understanding of plastic part design, injection molding, extrusion, and manufacturing processes
  • Must have experience in the design of complex engineering grade plastic parts, mold design, and processing of engineering grade resins
  • Ability to train and coach others from technical expertise
  • Must have experience with SolidWorks or other 3D modeling software
  • Experience with DFSS preferred

 

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