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 Director, Design Assurance 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, mentor, and develop a high‑performing team of Design Assurance Engineers supporting Agile Innovation Centers located across the globe.
• Foster a culture that prioritizes quality by design, proactive risk management, and strong collaboration with R&D partners.
• Allocate resources across multiple programs, based on risk, complexity, and business priorities.
• Build a global network of Design Assurance best practices consistent with top med‑tech companies.

• Ensure design assurance activities fully comply with FDA 21 CFR 820.30, ISO 13485, EU MDR, and other relevant global regulations.
• Oversee the creation and maintenance of Design History Files (DHF) and Medical Device Files (MDF) throughout the product lifecycle.
• Guide teams in developing clear, unambiguous, and testable requirements that flow logically from user needs, intended use, and risk analysis.
• Drive best‑in‑class design input/output processes aligned with industry standards.

• Provide expert input on sampling strategies, statistical methods, and verification & validation (V&V) approaches.
• Serve as a key participant in Agile ceremonies, sprint planning, backlog refinement, design reviews, and technical decision‑making.
• Ensure effective integration of risk management (ISO 14971) into all design decisions, including hazard analysis, FMEAs, and mitigations.
• Support hardware, software, and system‑level product development, ensuring regulatory‑grade documentation.

• Partner with Product Owners and System Architects to ensure quality considerations are incorporated into backlogs, epics, features, stories, and acceptance criteria.
• Work within Agile sprint cycles to verify that incremental design deliverables meet regulatory and company quality expectations.
• Promote rapid, iterative learning while maintaining robust traceability, change control, and regulatory documentation.

• Ensure compliance with design change requirements, including controlled updates to requirements, risk files, and V&V evidence.
• Support post‑market design change activities with rigorous quality oversight.
• Collaborate with manufacturing, supplier quality, and regulatory teams for seamless design transfer and change implementation.

• Identify opportunities to modernize design assurance processes, tools, and systems to support Agile innovation.
• Standardize global processes, templates, and best…