Sr. Design Assurance Quality Engineer

Sr. Design Assurance QEResponsible for overall Design Quality process to ensure that company design control projects comply with internal design control and risk management procedures in accordance with FDA, and ISOLead cross functional teams to implement and periodically review hazard analyses, risk assessment and other risk management processesProvide guidance to project team members to ensure that design control requirements are being met in an effective mannerSupport development, implementation and maintenance of Design Verification & Validation methodologiesCollaborate with Operations and Quality team members to ensure effective and successful design transfer to manufacturingDrive quality focused design and development of device software by defining the requirements, design, verification and validation plansParticipate in product cybersecurity activities including product security planning, threat analysis, cybersecurity risk assessments, periodic monitoring and reportingAct as a subject matter expert for Quality Engineering practices, such as statistical analysis, failure investigations, hazard identification, and quality data trending and analysisAssist in Post-Market Surveillance (PMS) initiatives, including failure investigation, record review, and data trendingEducation/Experience:BS in Mechanical, Electrical, or Biomedical Engineering5-8 years of design assurance experience in medical device design and manufacturing environmentProven track record of completing new product introduction transfers to OperationsWorking knowledge of Medical Device Regulation FDA 21 CFR 820 and ISO 14971, 13485, ISO 10993, IEC 60601 and IEC 62304 series of standards, other applicable regulations and industry standards pertaining to the design of medical devicesExperience with preparing and reviewing design documentation in support of regulatory submissionsWorking knowledge with various quality tools such as Failure Mode and Effects Analysis (FMEA) and Use Related Risk Analysis (URRA), Statistical Process Control (SPC), Root Cause Analysis (RCA), Measurement Systems Analysis (MSA) & Gage Repeatability and Reproducibility (Gage R&R)