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Engineer in Minneapolis, MN at Volt

Date Posted: 5/22/2019

Job Snapshot

Job Description

Volt has an opportunity for an Engineer for our client located in Plymouth, MN

Volt's Client is an American healthcare company that has a broad range of branded generic pharmaceuticals, medical devices, diagnostics, and nutrition products.

Job Duties:

EU MDR R&D Engineer

  • 3-7 years’ experience
  • Familiar with design controls and implantable devices
  • Continuous improvement / sustaining engineering experience
  • Previous work on U.S. class II or class III devices, class III preferred
  • Design assurance / development quality experience a plus
  • Experience working with nitinol a plus
  • Experience working with mechanical devices a plus
  • Working knowledge of the E.U. medical device regulation a plu

Job description:

  • Engineer with work on cardiac occluders and associated delivery system - remediation and continuous improvement activities
  • Perform, summarize and present research to assist the team in meeting project requirements
  • Participate in or lead problem-solving investigations
  • Develop or improve test methods utilizing skill sets including mechanical design, prototyping, problem solving and measurement systems analysis
  • Work with cross-functional teams to establish the device lifetime for each product
  • Support materials compliance teams with BOM, identification and verification of patient contacting and invasive component list
  • Updates to DHF, design inputs/outputs and product specification as applicable (from detailed gap assessment)
  • Update CAD files, design prints as necessary (materials compliance)
  • Support design quality engineers with risk management updates (frequency of occurrence and assessment of risks)
  • Ensure biocompatibility documentation is complete, update as necessary with shared biocompatibility services
  • Execute V&V work (to current standards as applicable)
  • Support inputs for General Safety and Performance Requirements (GSPR)

Volt is an Equal Opportunity Employer