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Dedicated engineers and equipment to help you quickly prototype innovative medical devices.
Advanced manufacturing technologies, purpose-built equipment, and vertically integrated capabilities.
Technology to collect critical data and power implantable medical devices.
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Open Positions

SR Design Development Engineer

Boston/Westborough

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