SR Design Development Engineer

Katherine Schultz

  • All locations
  • San Diego
  • San Deigo


Part of a cross-functional engineering team driving the design, development, verification, and manufacturing transfer of novel interventional medical devices.


  • Lead project teams through novel interventional device development while providing technical oversight, budget and timeline management, and effective customer communication
  • Set direction on core technical strategies for development programs
  • Mentor junior resources
  • Summarize and refine product specifications
  • Brainstorm novel therapeutic concepts
  • Perform concept refinement and generate detailed CAD design
  • Prototype and evaluate catheter-based designs
  • Perform engineering calculations, including tolerance analysis
  • Develop and maintain drawing packages
  • Develop in-vitro test methods, including fixture design and fabrication
  • Perform in-vivo and in-vitro study protocol development, execution, reporting
  • Develop manufacturing processes and documentation
  • Create and maintain design controls documentation
  • Generate product risk analyses
  • Foster client relationships and provide responsive service in a contract environment
  • Adhere to Quality Management System procedures/design controls
  • Participate in internal technical or process improvement initiatives
  • Prepare proposals, including definition of scope, timeline, and budget
  • Other duties as assigned


  • A minimum of 5 years’ experience in medical device development
  • Proficiency in MS Office suite and SolidWorks
  • Attention to detail and comfort working in a regulated industry
  • Ability to present and convey complex engineering ideas to internal stakeholders and external customers
  • Ability to create job-related documentation for quality purposes
  • Ability to quickly and positively adapt to changing priorities and processes (product of input on multiple projects in customer-driven environment)
  • Strong communication and organizational skills
  • Ability to work under minimal supervision
  • Familiarity with ISO 13485 and 21 CFR


  • Technical degree in Mechanical or Biomedical Engineering
  • Familiarity with design for manufacturability and design for assembly
  • Depth of knowledge in one or more clinical areas
  • Knowledge of probability and statistics
  • Experience in all phases of the medical device product development lifecycle
  • Project management experience


  • Standing and walking for short periods of time
  • Ability to use a microscope, including manipulating small objects under a microscope

If qualified, apply now. Job title and job location must be included in the application.

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Limitations And Disclaimer:

The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required for the position. Requirements are representative of minimum levels of knowledge, skills and/or abilities. To perform this job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.

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