Manager, Design Quality 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

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.

Responsible for all activities related to design quality assurance at Permobil Americas. Leads a team that oversees compliance to design control, design transfer and design change processes. Works in close collaboration with Product Marketing and R&D to ensure design quality is established and maintained at the highest level.

• Manage and lead a team of Design Assurance Quality Engineers located across multiple design centers
• Provide Americas input for engineering activities at other regional design centers. Ensures effective transfer of designs into US contract manufacturing sites.
• Ensure audit readiness of design activities; supports internal and external audits
• Represent the quality function at project and product portfolio governance boards
• Works with Marketing & R&D leadership to evaluate new projects, assign quality resources to core teams, monitor progress and manage escalations
• Evaluate competency of personnel and builds a team that is focused on results to effectively improve design and quality of products
• Define and monitors performance metrics related to design robustness
• Maintain quality system procedures related to design controls and design changes
• Drives standard work and best practices across design centers; design inputs are clear and unambiguous, requirements are properly decomposed, EDOs are identified, acceptance criteria are established in test plans/protocols, etc.
• Ensure team actively and effectively participates in technical design reviews and project tollgate reviews
• Assists Engineering in identifying regression test plans for design changes
• Develop and mentor team members of varying experience levels
• Work closely with System Engineers responsible for product risk management compliance to ISO 14971. Participates in risk evaluation and assessment activities during pre and post-production processes.
• Participate in the CAPA process and advocates with Marketing & R&D for design changes to address post-market product issues.
• Working manager and may be assigned to NPD/Sustaining Projects, when needed

Requirements:

• Bachelors Degree in Engineering discipline
• 5+ years of experience in the medical device industry, 3 years of experience in a leadership capacity (Project Management)
• Familiarity with medical device standards and regulations including 21 CFR Part 820, EU MDR, ISO 13485 and ISO 14971Experience with FDA Class I and Class II medical device design and development
• Risk management, top-down (HHA) and bottom-up (FMEA) risk evaluation methods
• Utilizing Root Cause Analysis techniques (e.g. 8D, 5-why, Ishikawa, Fault Tree Analysis, etc.)
• Statistical analysis techniques for verification and validation
• Excellent communication skills and ability to work with cross functional teams
• Ability to teach, mentor and provide expert application of Design Quality concepts and tools such as Verification vs. Validation, Requirements Development and decomposition, product Risk Management and FMEA

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

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.

Information
Please apply via our career page no later than xx. We will conduct selection continuously so send us your application today!

For additional information about the position, please contact Manager title, Manager name, Manager Contact information.
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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 1600 team members in more than 15 countries around the world. For more information regarding the company’s storied history and complete product line, visit permobil.com.

Fun facts about us: One of our products was 1 of 100 best inventions in Time magazine in 2021
https://time.com/collection/best-inventions-2021/
https://time.com/collection/best-inventions-2021/6112517/permobil-explorer-mini/