Director, Design Assurance

Director, Design Assurance

Would you like to work in an international environment where you'll make a difference every day? At Permobil, we're looking for game-changers to join us as we innovate for individuals and develop the world's most advanced assistive solutions.

At Permobil, the people who use our products come first. Our purpose is to create advanced assistive solutions that make the lives of adults and children living with disabilities more enriching. Our people are passionate about pushing the boundaries of technology to deliver innovations that improve lives. We are a sustainable and responsible business committed to continuous improvement, and our customers can trust us to provide market-leading solutions driven by insights-based clinical data.

The Design Assurance Director is a key Quality leadership role responsible for embedding quality and regulatory compliance into the design and development of innovative medical devices. This leader manages a team of Design Assurance Engineers (DAEs) who are co-located with cross-functional Agile R&D teams at Innovation Centers across the globe.

The ideal candidate has a strong passion for designing quality into the product from concept through commercialization. They partner closely with Product Owners, System Architects, Scrum Masters, and engineering teams to ensure that products are safe, effective, reliable, and compliant with international regulations. This role upholds world-class design control practices, drives clear and testable requirements, oversees verification and validation quality, and ensures complete and compliant DHF/MDF documentation.

• Lead and develop a high-performing global Design Assurance team, driving a strong quality-by-design culture and effective collaboration with R&D
• Ensure compliant design control execution across the product lifecycle in accordance with FDA 21 CFR 820.30, ISO 13485, EU MDR, including DHF and MDF ownership
• Drive clear, testable, and traceable design inputs and outputs aligned with user needs, risk management (ISO 14971), and industry best practices
• Act as a Design Assurance subject matter expert, guiding V&V strategies, statistical methods, and regulatory-grade documentation for hardware, software, and systems
• Partner with Product Owners and R&D within Agile frameworks to embed quality and regulatory requirements into backlogs, sprints, and design reviews
• Oversee compliant design change and lifecycle management, supporting design transfer, post-market changes, and cross-functional implementation
• Standardize and modernize global design assurance processes, tools, and templates while contributing to long-term Quality & Regulatory strategy

• Bachelor's or Master's degree in Engineering, Science, or related technical field
• 7+ years of experience in medical device R&D, quality engineering, or design assurance
• 3+ years of leadership or people management experience is preferred
• Strong working knowledge of FDA 21 CFR 820, ISO 13485, EU MDR, ISO 14971, and design control best practices
• Experience in both hardware and software product development environments
• Experience at major med-tech organizations or similar high-regulation environments
• Working knowledge of IEC standards for medical electrical equipment or software (e.g., IEC 60601, IEC 62304)
• Strong statistical knowledge and experience with V&V sampling methodologies
• Experience implementing or supporting global design assurance frameworks
• Demonstrated success partnering with engineering teams in an Agile development model

You are an experienced Design Assurance leader with a strong background in regulated medical device development, combining deep regulatory expertise with a modern, Agile mindset. You thrive in leading and developing global teams, partnering closely with R&D to embed quality by design throughout the product lifecycle. With solid hands‑on experience across hardware and software, strong knowledge of global regulations and standards, and a data‑driven approach to risk management and V&V, you are comfortable setting direction, driving consistency at scale, and influencing quality…