Senior Design Quality Engineer at Switchback Medical – BROOKLYN PARK, Minnesota

Essential Duties and Responsibilities (but not limited to):

• Own creation and implementation of all design control deliverables
• Lead on-time Design Verification and Design Validation (and support Process Validation IQ/OQ/PQ/PPQ) planning & execution
• Actively participate in and contribute to core team and customer facing meetings
• Drive meaningful translation of User requirements into discrete, objective, measurable, verifiable, and traceable Product requirements
• Oversee risk management activities throughout the device life cycle - from product concept through post launch
• Create accurate and repeatable test & inspection methods
• Support creation and execution of biocompatibility and sterilization qualifications
• Analyze data and prepare product test reports
• Oversee content of the Design History File, its completeness and integrity
• Ensure component specifications are properly defined and evaluated through the creation of supplied component sampling plans, First Article Inspections and supplier process qualifications
• Support supplier management activities and external audits
• Support external audit and certification efforts conducted by customers and regulatory bodies
• Support manufacturing lines by resolving components issues or other manufacturing barriers in a timely manner.
• Oversee and approve document change requests, non-conformances, deviations and special work order processes
• Lead root cause analysis and resolution activities
• Review and approve equipment specifications and qualification