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Consultant, Product Development Engineer, EU MDR, Medical Devices

Company: GForce Life Sciences
Location: Youngstown
Posted on: November 27, 2019

Job Description:

Consultant, Product Development Engineer, EU MDR, Medical Devices -Summary Our client, a global medical device company, has engaged GForce Life Sciences to identify a Product Development Engineer to guide and manage efforts related to the EU MDR Regulations. Duties / Expectations of Role Responsibilities may include, but are not limited to: Review existing design history files, identify scope, and mark gaps where necessary documents are missing Review, revise, and/or generate input/output tables or trace matrices (DCTMs) Generate or analyze and update existing risk documentation (DFMEA or risk tables) Coordinate, prepare, and conduct design reviews with cross-functional teams Perform tolerance stack-ups Generate comprehensive protocols to test/analyze the product for design verification and design validation (V&V) Generate design assurance documentation for the project Update prints and other design and manufacturing elements Update risk assessments to improve harm definitions to align with ISO 14971:2012 and 2017 EU MDR Update risk assessments to ensure consistency of failure severity ratings Ensure all risks identified in Design Risk assessments are aligned with labeling and product complaint data Manage timelines to meet defined goals for file completion dates Mandatory RequirementsBachelor's degree in Mechanical Engineering or related field 4 + years of industry experience Experience working within the quality systems established for medical device development and a basic understanding of relevant ISO standards A clear and demonstrated understanding of the mechanical testing required to meet the protocols set forth for device approval by the FDA Experience managing product development projects and carrying out day-to-day, hands-on R&D activities in addition to providing subject matter expertise Technical engineering skills including CAD modeling, drawing creation, etc Demonstrated ability to generate complex mechanical designs, Working knowledge of basic manufacturing processes and environments Ability to clearly communicate complex concepts and ideas Technical knowledge in development methodologies, design, and project implementation Must be able to work with minimal oversight by understanding the goal of the project and running with it Proficiency in applicable software project management and engineering software (in addition to Microsoft Office applications) Nice to Have RequirementsAdvanced degree in Biomechanical Engineering or Biomedical Engineering is preferred Experience with EU MDR Regulations 10+ years of experience working directly on the development and testing of medical device products Term 10+ months Onsite in Northern Ohio

Keywords: GForce Life Sciences, Youngstown , Consultant, Product Development Engineer, EU MDR, Medical Devices, Engineering , Youngstown, Ohio

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