Principal Design Quality Engineer

Job Description

Job Description

Summary :

The Design Quality Engineer leads design control efforts to develop new and improve existing medical devices. Works closely with various functions, including R&D and Product Development core teams to ensure appropriate design controls are established and achievable. Also supports process development, manufacturing related design changes, maintaining regulatory compliance, manufacturability improvements, and cost reduction efforts.

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 activities
• Develop / coach / mentor Design Quality Engineering Technicians

Essential Duties and Responsibilities (but not limited to) :

Education / Experience / Skills :

Desirable qualifications below :

This job description is intended to describe the general nature and level of work being performed by employees assigned to this position. It is not intended to be an entire list of all activities, tasks and skills required of employees in this position.