Principal Design Assurance Engineer

Description

• Mentor and train team members in quality system processes, risk management, and design assurance best practices.
• Stay current with emerging regulations, standards, and global quality system requirements; proactively integrate these changes into company procedures.
• Participate in internal and external audits, regulatory inspections, and technical reviews, providing expert interpretation of quality system and regulatory expectations.
• Lead the development, review, and approval of Design History Files (DHF), Device Master Records (DMR), and risk management documentation in compliance with FDA, ISO, and IEC standards.
• Partner with R&D and Systems Engineering to ensure design inputs and outputs are clearly defined, traceable, and verifiable.
• Serve as a subject matter expert in design control, risk management, and product validation, guiding teams through all phases of development and sustaining engineering.
• Provide technical leadership for design assurance activities across multiple, concurrent product development programs.
• Develop and implement verification and validation strategies, ensuring comprehensive test coverage and alignment with design requirements.
• Analyze testing and field performance data to identify systemic risks and drive continuous improvement initiatives.
• Collaborate cross-functionally with Quality, Regulatory, Operations, and Project Management to ensure robust product realization processes.

Requirements

• Familiarity with software validation, usability engineering, and human factors testing.
• Proficiency in statistical software tools (e.g., Minitab) and data-driven decision-making methods.
• Extensive knowledge of FDA QSR, ISO 13485, ISO 14971, and IEC 60601 standards and their application in product development.
• Minimum of 10 years of experience in design assurance, quality engineering, or product development within the medical device industry.
• Prior experience leading design assurance teams or serving as a technical lead across multiple development programs.
• Deep understanding of design control principles, risk management, and product lifecycle management for Class II and III devices.
• Proven ability to lead risk-based decision-making within cross-functional teams.
• Bachelor’s degree in Mechanical, Engineering, Biomedical Engineering, or a related technical discipline (Master’s preferred).
• Strong organizational, analytical, and problem-solving skills with a focus on process improvement and efficiency.
• Proven success developing and executing verification and validation plans, including statistical analysis and sample size justification.
• Demonstrated experience supporting regulatory submissions (510(k), PMA, or MDR technical files).
• Advanced training or certification in quality systems or risk management (e.g., ASQ CQE, RAC, ISO 14971).
• Exceptional communication skills with the ability to influence and guide cross-functional teams and stakeholders.
• Experience managing CAPA investigations, audit responses, or post-market surveillance initiatives.

Benefits

• Short- and long-term disability, life insurance, and additional voluntary benefits.
• Paid holidays, vacation, and personal time off.
• Comprehensive health, dental, and vision coverage.
• Competitive compensation package based on experience and qualifications.
• Professional growth opportunities within an innovative and collaborative team environment.
• 401(k) plan with company match.

Training + Development

Interview process

Visa Sponsorship

Security clearance