Director, Design Quality

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee, develop, and allocate resources for Design Quality Engineering teams across both hardware and software areas.

• Provide leadership and oversight for design controls, design transfer, risk management, verification and validation, human factors, and product lifecycle activities.

• Collaborate with cross-functional leaders to define quality strategies, requirements, decision-making points, and escalation procedures.

• Enhance processes, metrics, and governance related to the Quality Management System for design.

• Leverage complaint, field-performance, and post-market data to identify product risks and prevent recurrence.

• Act as the representative for Design Quality during FDA inspections, Notified Body audits, regulatory interactions, and executive management reviews.

• Ensure adherence to FDA regulations, international standards, and medical-device protocols.

• Foster and maintain a collaborative quality culture that is focused on patients and customers.

• Recruit, mentor, and develop leaders and teams, including planning for succession and building capabilities.

• Report on quality risks, performance metrics, resources, and improvement priorities to executive leadership.

• Execute additional tasks as assigned by management.

⛳️ Requirements

• A minimum of 15 years of relevant experience paired with a Bachelor’s degree; relevant experience encompasses the medical/science/healthcare field or an equivalent qualification.

• At least 5 years of managerial experience with direct reports.

• In-depth knowledge of Design Controls, Critical-to-Quality strategies, Risk Management, Cybersecurity, and related areas.

• Familiarity with mechanical, electrical, and software engineering in the creation of complex devices.

• Understanding of the software development lifecycle, including embedded software, firmware, application software, and analytics.

• Experience with software quality for mobile applications and remote installations is advantageous.

• Ability to collaborate and build constructive relationships and trust with diverse audiences across disciplines.

• Experience with AI-driven devices, Software as a Medical Device (SaMD), and/or wearable medical devices is preferred.

• A Master's or advanced degree is preferred.

• Knowledge of FDA requirements, 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 82304, IEC 62366, EU MDR, and other applicable international regulations and standards.

🏝️ Benefits

• Medical, dental, and vision insurance commencing on the first day.

• Paid holidays.

• Paid Time Off (PTO).

• 401K plan with company matching.

• Employee Stock Purchase Plan.

• Paid parental leave.

• Discounted pet insurance.

• Participation in Cultural Committee and Charity events.

• Reasonable accommodations for qualified individuals with disabilities during the job application process.