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.

Position Overview

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.

Key Duties:

Leadership & Team Management
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.

Quality by Design / Design Control Ownership
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.

Subject Matter Expertise
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.

Agile Development Quality Partnering
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.

Design Change & Lifecycle Management
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.

Continuous Improvement & Strategy
Identify opportunities to modernize design assurance processes, tools, and systems to support Agile innovation.
Standardize global processes, templates, and best practices for design control and risk management across all R&D sites.
Contribute to long-term Quality & Regulatory strategic planning as part of the global leadership team.

Education/Certification:
Bachelor's or Master's degree in Engineering, Science, or related technical field.

Knowledge Required/Key Competencies:
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.

Experience Required:
Minimum 10+ years of progressive experience in medical device R&D, quality engineering, or design assurance.
Minimum 5+ years of people leadership experience
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.
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 Permobil is a great next step for you!

1. You'll make a difference. Every day.

Everything we do leads to understanding and improving the lives of our users. Through our evidence-based innovation, we make a difference to people's lives.

2. You'll make your mark as part of our future

We collaborate with colleagues across borders to Innovate for Individuals. The impact you make personally could lead change around the world.

3. You'll feel welcome from day one

We're known for being great colleagues, who are collaborative, fun and at the cutting-edge. Everyone in the Permobil family cares as much as you do about making a positive difference.

4. You can have a lifestyle you love

In Lebanon you're always close to nature, yet never far from civilization. We want everyone who works for us to have a lifestyle they love - at work and beyond.

Information
Please apply via our career page. We will
conduct selection continuously so send us your application today!

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At Permobil, diversity fuels our innovation in creating life-changing mobility solutions. We embrace the unique talents and perspectives of individuals from all backgrounds to drive our mission forward. Join Permobil and be part of a team where diversity is not just valued, but essential to our success in delivering personalized mobility solutions.

Permobil is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Please respect that we do not wish recruitment assistance or advertising, we decline calls from recruitment and advertising providers.

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 Udden 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 1900 team members in more than 18 countries around the world. For more information regarding the company's storied history and complete product line, visit permobil.com.