EU MDR R&D Engineer

Job Title : EU MDR R&D Engineer

Duration : 1+ Years

Location : Plymouth, MN

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

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)