Key position working closely with R&D, Operations, Commercial, Regulatory and Operations Quality to ensure compliance with QMS and FDA QMSR requirements.
Duties:
- Provide QE for Product Development Projects throughout all phases of Design Controls (Concept to Launch) and Design Risk Management for Class III devices with disposables, software, and electromechanical components.
- 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, ISO and other applicable requirements. - Lead cross functional teams to implement and review hazard analyses, risk evaluation, assessment and other risk management processes
- Provide guidance to project team members to ensure that design control requirements are being met to effectively achieve quality by design
Support development, implementation and maintenance of Design V&V methodologies and best practices to impact product quality and launch timeliness. - Collaborate with Operations and Operations Quality 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 plan and
strategies while maintaining traceability and compliance to IEC 62304 and FDA guidance documents related to medical device software. - Participate in product cybersecurity activities including product security planning, threat analysis, cybersecurity risk assessments, monitoring and reporting.
- Serve as SME for QE practices, such as statistical analysis, failure investigations, hazard identification and risk analysis, and quality data trending and analysis
- Assist in Post-Market Surveillance initiatives, including failure investigation, record review, and data trending.
Qualifications: - BS in Mechanical, Electrical, or Biomedical Engineering or related discipline.
- 6-10 years of design assurance experience in a complex medical device design and manufacturing environment.
- Proven record of completing new product introduction transfers to manufacturing.
- Working knowledge of MDR FDA 21 CFR 820 and ISO 14971, 13485, ISO 10993, IEC 60601 and IEC 62304 series of standards, other applicable regulations and standards.
- Experience preparing and reviewing documentation in support of regulatory submissions.
- Working knowledge of data analysis methods, including basic statistics, preferably using Minitab or other similar data analysis software.