Director of Design Assurance

Job Summary

Leading the Sustaining Design Assurance Organization, the full-time Director of Design Assurance will provide strategy, execution, and oversight for new product development and lifecycle engineering while mentoring teams in Japan and potentially India, all within a remote work environment.

Key responsibilities

• Mentor and lead engineering staff in Japan on new product development and sustaining engineering projects
• Champion risk management practices and ensure compliance with regulatory standards throughout the product lifecycle
• Collaborate with senior management on project, process, and quality decisions while supporting facility audits

Required qualifications

• BS degree or equivalent in engineering or life sciences
• 10-15 years of professional experience in quality or engineering, with at least 5 years in medical device new product development management
• Proven track record in global execution of new product development focused on product quality
• Strong technical skills in Design Assurance, including risk management and regulatory standards
• Demonstrated ability to drive product differentiation and continuous improvement