Design Quality Assurance Engineer

Design Quality Assurance Engineer

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 Purpose:
The Design Assurance Engineer (DAE) plays a critical role in ensuring that innovative medical devices are designed with quality, safety, and regulatory compliance built in from the start. Working as an integrated member of cross functional Agile Innovation teams, the DAE supports the full product development lifecycle-from concept through commercialization.
This role ensures that design inputs, risk management, verification and validation (V&V), and design documentation meet global regulatory requirements and internal quality standards. The DAE partners closely with Engineering, Product Owners, System Architects, and other Innovation stakeholders to deliver high quality, reliable, and compliant medical devices.

Key Tasks:

Quality by Design / Design Control Execution

• Execute design assurance activities in compliance with FDA 21 CFR 820.30, ISO 13485, EU MDR, and other global regulations.
• Support creation, organization, and maintenance of Design History File (DHF) and Medical Device File (MDF) documentation.
• Develop and review clear, testable, and traceable design requirements derived from user needs, intended use, and risk analysis.
• Ensure robust design input, design output, and design verification processes aligned with industry best practices.

Technical & Regulatory Subject Matter Support

• Provide input on sampling plans, statistical methods, and V&V strategies.
• Participate actively in Agile ceremonies including sprint planning, backlog refinement, design reviews, and technical discussions.
• Integrate ISO 14971 risk management requirements into design decisions, supporting hazard analyses, FMEAs, and mitigation documentation.
• Support hardware, software, and system-level development with regulatory grade documentation.

Agile Development Quality Partnering

• Collaborate with Product Owners and System Architects to ensure quality requirements are accurately represented in backlogs, epics, features, and stories.
• Review incremental design deliverables within sprint cycles, ensuring compliance with regulatory expectations.
• Maintain traceability, change control, and other design control elements within the Agile framework.

Design Change & Lifecycle Management

• Support controlled updates to requirements, risk files, V&V documentation, and design outputs during design changes.
• Contribute to post market design change activities, ensuring updates are compliant and appropriately documented.
• Collaborate with manufacturing, supplier quality, and regulatory functions to ensure effective design transfer and lifecycle management.

Continuous Improvement

• Identify opportunities to improve design assurance processes, templates, tools, and systems.
• Share and promote best practices across global R&D teams.
• Support initiatives to modernize design control and risk management processes.

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

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.

Who you are
You are passionate, innovative, and ambitious. You want to make a difference for others and feel fulfilled when you can see the link between the work you do and positive improvements in the lives of others. You search out opportunities and are prepared to go off the beaten track to chase your dreams. You don't follow the herd - you find new ways of working and go where you see potential to make your mark. You are a pioneer, a revolutionary, a game-changer and you are who we're looking for.

Your Background

• You have a Bachelor's or Master's degree in Engineering, Science, or related technical field.
• Minimum 3-7 years' experience in medical device R&D, quality engineering, or design assurance.
• Experience with both hardware and software development environments is preferred.
• Knowledge of FDA 21 CFR 820, ISO 13485, EU MDR, ISO 14971, and industry-standard design control practices.
• Experience working within Agile development teams strongly preferred.
• Understanding of medical device regulations and design control requirements.
• Working knowledge of relevant IEC standards (e.g., IEC 60601, IEC 62304).
• Strong foundation in statistics and sampling approaches for V&V.
• Ability to work effectively in a global design assurance framework.
• Strong communication, analytical thinking, and collaboration skills.
• Other qualifications or experiences.

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.

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.