Director of Design Assurance

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