Staff Design Engineer

US-CA-Rancho Santa Margarita

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Applied-Medical-Logo-w-Tag_H_Teal_cropped

 

Staff Design Engineer

 

Applied Medical is a rapidly growing, global organization that develops, manufactures and distributes medical devices to more than 75 countries. Our driving purpose is to satisfy the three fundamental healthcare needs: enhanced clinical outcomes, outstanding value and unrestricted choice. For 30 years, Applied Medical has been at the forefront of innovation and technology. As a result of our highly vertically integrated business model, we control all of our processes in-house, from R&D concept to clinical implementation. Applied Medical engineers take a hands-on approach, utilizing in-house cutting-edge technologies, such as automation and robotics, advanced metal processing, injection molding, and rapid prototyping. We invest heavily in R&D, advanced technologies and most importantly – the growth of our team members.                                                                                

Applied Medical is proud to have a culture firmly grounded in teamwork, collaboration and regulatory compliance, while providing opportunities for growth and choice in individual career paths.

Position Description

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.

 

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

  • 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

  • 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

Benefits

  • Training and mentorship with ongoing learning and development courses
  • On-campus wellness activities
  • Comprehensive medical and dental coverage
  • Education reimbursement program
  • 401(k) program with employer match
  • Generous holiday and vacation accrual

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