Principal Design Quality Engineer

Roles & Responsibilities

• Participate in NPI and design changes, DHF, and DMR reviews meetings.
• Understand and adhere to the design control process and Quality Engineering.
• Resolve issues creatively, ensuring projects meet customer and regulatory requirements.
• Act as a subject matter expert on design control process and Quality Engineering.
• Provide guidance to engineering staff and ensure design control requirements are met.
• Review DHF files for accuracy and completeness, and provide guidance on FDA compliance and procedures.
• Coordinate Design Assurance activities and assist with complex tasks requiring judgment and initiative.
• Create processes and process improvements to ensure consistent implementation of internal requirements and external regulations.
• Represent the design quality functions for review and approval of designated design outputs.
• Mentor and assist junior level staff with more complex tasks.
• Assist with various projects as assigned.

Qualifications

• Bachelor's Degree required; Advanced Degree preferred.
• 8-12+ years of experience or a master's degree and 6+ years of experience preferred.
• Familiarity with critical elements of the design history file including risk management, design verification, and validation tests.
• Ability to multi-task and operate within a fast-paced environment.
• Strong organizational and presentation skills.
• Excellent oral, written, analytical, computer, and interpersonal skills.