Principal Design Quality Engineer

The Principal Quality Engineer will apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Synaptic systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Provide engineering solutions in the areas of Quality Assurance, Design Controls, Risk Management, and Statistical Techniques
• Lead design assurance and development activities (i.e., engineering studies, feasibility testing, drawing reviews, etc.) for new product development programs
• Lead creation and maintenance of risk management files in accordance with ISO 14971 and applicable regulations (plans, hazard analyses, FMEAs, software hazard analysis, reports, etc.)
• Develop quality assurance specifications, test methods, inspection procedures, sampling plans, and related written procedures.
• Lead test method development and validation activities.
• Support new product launch, master validation plans, product V&V, process validations, and design transfer into manufacturing .
• Daily support of production requirements and issues through active involvement & presence in the assembly operations. Continual improvement of methods & systems towards full compliance and world class manufacturing.
• Implement and review changes to existing products, SOPs, Work Instructions, Test Methods, Process Changes, Design Changes, Labeling, and Field Issues to define the requirements for regulatory submissions and notifications.
• Support and prepare documentation for regulatory submissions and worldwide registrations.
• Working knowledge of Software Development Life Cycle Processes in accordance with IEC 62304
• Working knowledge of Usability Engineering Processes in accordance with IEC 62366
• Support the Supplier Evaluation, Selection, and Qualification processes.
• Perform additional duties as required.

EDUCATION and/or EXPERIENCE

• Bachelor's Degree in Engineering or Scientific related field with 6 years of Quality Engineering, Quality Manufacturing, and/or R&D experience; OR Master's Degree in Engineering or Scientific related field with 5 years of Quality Engineering, Quality Manufacturing, and/or R&D experience
• Hands-on experience with Design Assurance, including Design Controls, Design Freeze (or pre-design freeze feasibility testing), Design Verification & Validation, and/or Design Test Method Development
• Experience working within a highly regulated industry

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