SR Design Development Engineer

Katherine Schultz

  • All locations
  • San Diego
  • San Deigo

DESCRIPTION:

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

RESPONSIBILITIES:

  • 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

REQUIRED QUALIFICATIONS:

  • 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

PREFFERED QUALIFICATIONS:

  • 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

PHYSICAL DEMANDS:

  • 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.

To apply for this job, email your details, the job title and job location to hr@resonetics.com

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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