Staff Design Engineer

US-CA-Rancho Santa Margarita

Overview

As a Senior Staff Design Engineer, you will lead the design and development efforts for medical devices within the framework of a cross-functional team.


 


Responsibilities


Provide guidance on and complete the following:



  • Create medical device designs to meet users’ needs from concept to implementation.

  • Build functional prototypes for device development.

  • Perform root cause analysis on component and product failures, and implement corrective actions in order to improve products and processes

  • Improve designs in design reviews

  • Understand clinical needs and relevant surgical procedures to interpret users’ needs in order to create relevant design requirements and specifications

  • Review engineering documents such as instructions, drawings, test procedures, and reports for accuracy and compliance.

  • Coordinate the documentation of design efforts for the Design History File

  • Research and qualify new technologies, materials, and manufacturing processes

  • Teach, guide and mentor other team members in your areas of expertise to help with technical development

Position Requirements

Requirements



  • 10+ years of experience in mechanical design

  • Demonstrate extensive experience in mechanism design

  • Bachelor’s Degree in Mechanical, Biomedical, Industrial, or Manufacturing Engineering (or equivalent) 

  • Experience with working hands-on to create prototypes

  • Mastery of CAD modeling and drafting (i.e. Solid Works)

  • Mastery of Geometric Dimensioning and Tolerancing (GD&T)

  • Advanced knowledge of component and mechanism design and design for manufacturing  (Molded parts, Stampings, Machined parts)

  • Excellent organization, communication, and technical writing skills

  • Ability to understand, analyze, and troubleshoot complex systems

  • Ability to develop innovative solutions to complex problems

  • Ability to work effectively in cross-functional teams


 


Preferred Qualifications



  • Experience in the medical device industry

  • Knowledge of surgical procedures and clinical needs

  • Understanding of manufacturing and quality standards, including FDA regulations and ISO quality systems

  • Exposure to FMEA and Test Method Validation

  • Experience with software such as Netweaver / Product Life-Cycle Management

  • Experience with Minitab or statistical analysis software

  • Experience with leading teams or projects

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