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R&D Engineer Sr. in Minneapolis, MN at Volt

Date Posted: 2/11/2019

Job Snapshot

Job Description

Volt has an opening for a EU MDR R&D ENGINEER 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.

EU MDR R&D Engineer

Job description:

  • Engineer with work on cardiac surgery and transcatheter heart valve 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)

Requirements

  • Intermediate or Sr 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 tissue a plus
  • Experience working with heart valves a plus
  • Working knowledge of the E.U. medical device regulation a plus

This position is Non Exempt.

Volt is an equal opportunity employer

PLEASE NOTE: When calling in for this position, please call our Recruiter at: (602) 889-0711. Thank you.