| Responsible 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 ISO Lead cross functional teams to implement and periodically review hazard analyses, risk assessment and other risk management processes Provide guidance to project team members to ensure that design control requirements are being met in an effective manner Support development, implementation and maintenance of Design Verification & Validation methodologies Collaborate with Operations and Quality team members to ensure effective and successful design transfer to manufacturing Drive quality focused design and development of device software by defining the requirements, design, verification and validation plans Participate in product cybersecurity activities including product security planning, threat analysis, cybersecurity risk assessments, periodic monitoring and reporting Act as a subject matter expert for Quality Engineering practices, such as statistical analysis, failure investigations, hazard identification, and quality data trending and analysis Assist in Post-Market Surveillance (PMS) initiatives, including failure investigation, record review, and data trending Education/Experience: BS in Mechanical, Electrical, or Biomedical Engineering 5-8 years of design assurance experience in medical device design and manufacturing environment Proven track record of completing new product introduction transfers to Operations Working 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 devices Experience with preparing and reviewing design documentation in support of regulatory submissions Working 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) Experience with manufacturing complex medical devices, including process validation and equipment qualification requirements (IQ/OQ/PQ). |
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