Senior Engineer, Biomechanical Engineering

Company: The Judge Group
Location: Solon
Posted on: April 22, 2024

Job Description:

Our client is currently seeking a Senior Engineer, Biomechanical Engineering for an 18 month
contract.
JOB DESCRIPTION: Quality Engineering with focus on Design Improvements --- Develop knowledge with the following regulations and standards: o 21 CFR Part 820 - Medical Device Quality System Regulations (QSR) o ISO 13485:2016 Medical devices - Quality management systems o EN ISO 11135-1:2007 - Sterilization of healthcare products - Ethylene Oxide o EU Medical Device Regulation --- Assist in Non-Conforming material resolution including root cause investigation and communication with suppliers. --- Assist in Corrective and preventative action (CAPA) including root cause investigation and effectiveness check. --- Perform Design Verification/Validation --- Support supplier issue resolution. --- Perform data analysis/trending as requested and prepare quality improvement presentations.o Local Candidates only 100% on-site, open to Hybrid role. o Travel required? No o Years of experience? Degree plus 2 years o Software skills?
CAD, highly preferred o Medical device background required? No, highly preferred. o Any particular industries or Job Titles? QA or Manufacturing EngineerDay to Day:
o Design change.
o Verification and validation.o Document updates.
o Drawing updates.
o Data analysis.

Keywords: The Judge Group, Cleveland , Senior Engineer, Biomechanical Engineering, Engineering , Solon, Ohio