Address
Form of workDesign 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.Essential Duties
Works closely with and support R&D (Design & Systems Engineering) through specific phases of the NPD process.
Provide Quality Assurance support and guidance for product change activities: Design and Development Planning, Design Input, Design Output, Design Review, Design Verification and Validation, Design Transfer, as per FDA QSR 21 CFR 820.
Partner with R&D and Sustaining Engineering in Project Tollgate Reviews & ECO reviews.
Ensure traceability of requirements documentation through Design Verification and Design Validation.
Review and approve Design Verification and Validation test plans, protocols and reports. Use statistical techniques where applicable.
Participate with Systems Engineering on product Risk Management.
Manage and maintain Design History File.
Project Specific Duties
Support new product development of manual wheelchairs and power assist devices.
Support a cross-functional development team by providing guidance in executing a PDP process.
Support the PM with phase-gate deliverables to ensure that the PDP (Product Development Process) is successfully navigated.
Support the development of the Device Master and Device History Records.
Support Risk Management activities to define and assess hazards and harms associated with manual wheelchair designs and mitigate risks to the extent necessary.
Ensure that designs are manufacturable and that design transfers are robust.
Support efforts to recover when the team is behind schedule.
Support supplier qualification activities.
Support regulatory compliance activities for newly developed products.
Key skills and abilities -
Experienced in the application of FDA 21 CFR 820.30 and ISO 13485 for new product development.
Strong leadership, communication, and collaboration skills.
Ability to read and critique engineering drawings (GD&T) and test plans.
Strong technical writing skills.
Basic statistical knowledge.
ExperienceRequired:
Educational background - BS in Engineering preferred, but not required.
Employment background -
Previous manufacturing experience in a Quality Assurance role required.
Medical device experience preferred, but not required.
Experience in R&D and/or design engineering preferred.
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 civilisation. 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 seethe link between the work you do and positive improvements in the lives ofothers. You search out opportunities and are prepared to go off the beatentrack to chase your dreams. You don't follow the herd - you find new ways ofworking and go where you see potential to make your mark. You are a pioneer, arevolutionary, a game-changer and you are who we're looking for.
Information
Please apply via our career page no later than xx. We willconduct selection continuously so send us your application today!
For additional information about the position, please contact Manager title, Manager name, Manager Contact information.
For information about the recruitment process, please contact the recruiter, Recruiter Name, HR BP contact info.
For information regarding Permobil's Privacy Notice, please visit privacy.permobil.com
Permobil is an equal opportunity/affirmative action 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 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.
Permobil is an equal opportunity/affirmative action 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.
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/
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.Essential Duties
Works closely with and support R&D (Design & Systems Engineering) through specific phases of the NPD process.
Provide Quality Assurance support and guidance for product change activities: Design and Development Planning, Design Input, Design Output, Design Review, Design Verification and Validation, Design Transfer, as per FDA QSR 21 CFR 820.
Partner with R&D and Sustaining Engineering in Project Tollgate Reviews & ECO reviews.
Ensure traceability of requirements documentation through Design Verification and Design Validation.
Review and approve Design Verification and Validation test plans, protocols and reports. Use statistical techniques where applicable.
Participate with Systems Engineering on product Risk Management.
Manage and maintain Design History File.
Project Specific Duties
Support new product development of manual wheelchairs and power assist devices.
Support a cross-functional development team by providing guidance in executing a PDP process.
Support the PM with phase-gate deliverables to ensure that the PDP (Product Development Process) is successfully navigated.
Support the development of the Device Master and Device History Records.
Support Risk Management activities to define and assess hazards and harms associated with manual wheelchair designs and mitigate risks to the extent necessary.
Ensure that designs are manufacturable and that design transfers are robust.
Support efforts to recover when the team is behind schedule.
Support supplier qualification activities.
Support regulatory compliance activities for newly developed products.
Key skills and abilities -
Experienced in the application of FDA 21 CFR 820.30 and ISO 13485 for new product development.
Strong leadership, communication, and collaboration skills.
Ability to read and critique engineering drawings (GD&T) and test plans.
Strong technical writing skills.
Basic statistical knowledge.
ExperienceRequired:
Educational background - BS in Engineering preferred, but not required.
Employment background -
Previous manufacturing experience in a Quality Assurance role required.
Medical device experience preferred, but not required.
Experience in R&D and/or design engineering preferred.
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 civilisation. 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 seethe link between the work you do and positive improvements in the lives ofothers. You search out opportunities and are prepared to go off the beatentrack to chase your dreams. You don't follow the herd - you find new ways ofworking and go where you see potential to make your mark. You are a pioneer, arevolutionary, a game-changer and you are who we're looking for.
Information
Please apply via our career page no later than xx. We willconduct selection continuously so send us your application today!
For additional information about the position, please contact Manager title, Manager name, Manager Contact information.
For information about the recruitment process, please contact the recruiter, Recruiter Name, HR BP contact info.
For information regarding Permobil's Privacy Notice, please visit privacy.permobil.com
Permobil is an equal opportunity/affirmative action 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 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.
Permobil is an equal opportunity/affirmative action 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.
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/
