Many structural heart patients suffer from heart failure with limited options. The Implantable Heart Failure Management (IHFM) team is addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention.
Requirements
- Experience in both design and manufacturing environments
- Experience in medical device industry, preferably with electromechanical devices and medical device software
- ASQ Certified Quality Engineer
- Technical writing skills, experience creating SOPs in a Quality Management System
- Experience with quality principles and tools
- Capability in application of statistical techniques and sampling plans
- Skills in root cause analysis and determination of appropriate corrective action
Responsibilities
- Review and approve design verification and validation protocols and reports to ensure that test article selection, sampling rationales and test methodologies are technically sound and sufficient given level of risk and internal/external requirements.
- Review risk analyses and design and usability FMEAs for adherence to requirements
- Participate in design reviews to ensure customer and regulatory requirements have been properly translated into design inputs which are complete, unambiguous and do not conflict.
- Encourage continuous improvement in design control activities and proactive utilization of quality tools with design team.
- Support design for manufacturing in the design phase through design transfer to manufacturing, both internally and externally
- Support manufacturing process optimization to encourage reproducible quality outcomes
- Perform root cause analysis of field, incoming, and manufacturing issues and implement corrective actions.
Other
- Develop a thorough understanding of the entire product lifecycle for Endotronix product
- Provide quality engineering input to establishment of product specifications, quality plans, and manufacturing procedures which consider risk management
- Assist with management and monitoring of process control metrics in manufacturing environment.
- Develop sampling plans for quality assurance based on product risk and supplier performance
- Apply learned techniques and contribute to analysis and investigation to solve problems
