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.
Our purpose at Permobil is to create advanced assistive solutions that enrich the lives of adults and children living with disabilities. Driven by a passion for innovation, our people push the boundaries of technology to deliver market‑leading mobility solutions grounded in insights‑based clinical data. As a sustainable and responsible business on an exciting transformational journey, we are shaping a future free from mobility limitations - and your contribution can help make that future a reality.
Position Overview
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.
Key Responsibilities:
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Lead and develop a high-performing global Design Assurance team, driving a strong quality-by-design culture and effective collaboration with R&D,
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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,
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Drive clear, testable, and traceable design inputs and outputs aligned with user needs, risk management (ISO 14971), and industry best practices,
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Act as a Design Assurance subject matter expert, guiding V&V strategies, statistical methods, and regulatory-grade documentation for hardware, software, and systems,
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Partner with Product Owners and R&D within Agile frameworks to embed quality and regulatory requirements into backlogs, sprints, and design reviews,
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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.
Skills and Qualifications:
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Bachelor’s or Master’s degree in Engineering, Science, or related technical field,
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10+ years of experience in medical device R&D, quality engineering, or design assurance,
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5+ years of leadership or people management experience,
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Strong working knowledge of FDA 21 CFR 820, ISO 13485, EU MDR, ISO 14971, and design control best practices,
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Experience in both hardware and software product development environments,
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Experience at major med-tech organizations or similar high-regulation environments,
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Working knowledge of IEC standards for medical electrical equipment or software (e.g., IEC 60601, IEC 62304),
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Strong statistical knowledge and experience with V&V sampling methodologies,
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Experience implementing or supporting global design assurance frameworks,
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Demonstrated success partnering with engineering teams in an Agile development model.
Who are you?
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 strategy in a fast-moving, highly regulated environment.
Why is this role a perfect next step for you?
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You’ll make a difference. Every day.
Everything we do leads to improving the lives of the people who use our products. Through our evidence-based innovations, we make a difference to people’s lives. -
You’ll make your mark as part of our future.
We collaborate with colleagues across borders to Innovate for Individuals. The impact you personally make could change the world. -
You’ll feel welcome from day one.
We’re known for being great colleagues, who are collaborative, fun and at the cutting-edge. Everyone at Permobil cares as much as you do about making a positive difference.
Application Process
We will conduct selection continuously so send us your application today or before March 20th at the latest!
For more information about the position and recruitment process, please contact Mark Elliott, Executive Vice President Quality & Regulatory, [email protected]
For information about the recruitment process, please contact Zivile Mitkute, Talent Acquisition Partner, [email protected]
Permobil is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals.
Please respect that we do not wish recruitment assistance or advertising, we decline calls from recruitment and advertising providers.
More about Permobil
Permobil founder Dr. Per Uddén believed that helping people achieve the greatest level of independence is a basic human right and, for over 50 years, Permobil has held fast to that belief. Permobil is a global leader in advanced rehabilitation technology, passionate about better understanding our users’ needs and improving their quality of life through state-of-the-art healthcare solutions. Today, those solutions include power wheelchairs, seating and positioning products, power assist, and manual wheelchairs.
Permobil is part of Patricia Industries, a subsidiary of Investor AB, and is headquartered in Sweden. Permobil has 2 000 team members in 18 countries around the world. For more information regarding the company’s storied history and complete product line, visit permobil.com.
