Principal Design Quality Assurance Engineer - Endoscopy

Act as the primary voice for quality within cross-functional teams, influencing project direction and ensuring adherence to regulatory requirements and best practices. Lead execution of Quality Deliverables including Project Design & Development Plans, Field Assessment Plans, and Risk Management deliverables to ensure compliance with ISO 14971 and demonstrate a primary commitment to patient safety. Guide successful completion of major programs, function in project leadership roles, and act as the division representative on cross-divisional projects defining quality systems. Leverage deep technical knowledge to lead teams through complex problem-solving initiatives using systematic approaches like 5 Whys, DMAIC, and Six Sigma methodologies to diagnose root causes and optimize processes. Mentor engineers, foster a culture of learning, and establish strong relationships across departments to drive consensus among stakeholders. Proactively assess opportunities for improvements to quality systems and support internal and external regulatory audits as a subject matter expert. This hybrid role is based in Marlborough, MA, requiring on-site presence three days per week, with approximately 10-20% travel.