Biomechanical Engineering

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...........................................
Hiring Manager notes: o Local Candidates only 100% on-site, open to Hybrid role.
o Travel required? No
o Years of experience? Degree plus 2years
o Education requirement?
o Software skills?
CAD, highly preferred
o Medical device background required? No, highly preferred.
o Any particular industries or Job Titles? QA or Manufacturing Engineer
o Do you know of any local or national Stryker competitors that may have workers you would be interested in? no
Day to Day:
o Design change.
o Verification and validation.
o Document updates.
o Drawing updates.
o Data analysis.
Interview Process: 1st virtual & 2nd on-site
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