R&D Engineer in Plymouth, MN at Volt

Date Posted: 9/17/2020

Job Snapshot

Job Description

R&D Engineer (12-month contract)

Plymouth, MN

Volt has partnered with a growing manufacturing company in search of a R&D Engineer!

Responsibilities:

  • 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).

Requirements:

EU MDR R&D Engineer:

  • Bachelor’s Degree in engineering or Sciences.
  • 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 nitinol a plus.
  • Experience working with mechanical devices a plus.
  • Working knowledge of the E.U. medical device regulation a plus.

Volt is an Equal Opportunity Employer