Quality Assurance

3 weeks ago

New Berlin, United States Permobil, Inc. Full time

Design Engineer - Quality Assurance

Sponsorship is not available

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 (Product Development, Systems Engineering & PMO) through specific phases of the Product Development Process (PDP) on New Product Development (NPD) projects.
  • Provide direction and support for Design Controls per FDA 21 CFR 820.30 & ISO 13485 7.3: Design and Development Planning, Design Input, Design Output, Design
  • Review, Design Verification and Validation, Design Transfer
  • Provide DQA support and guidance for product change (ECO) activities.
  • Participate in NPD and Tollgate and Design 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 in Systems Engineering on product Risk Management.
  • Manage and maintain Design History File Index.

Project Specific Duties:

  • Support new product development of Seating & Positioning, (and possibly Manual Wheelchairs and Power Assist Device) projects.
  • Support the cross-functional team by providing guidance in executing the PDP process.
  • Support the PM with phase-gate deliverables to ensure that the PDP 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 if needed.
  • Support regulatory compliance activities for newly developed products.

Key skills and abilities:

  • Experienced in the application of Design Controls (FDA 21 CFR 820.30 and ISO 13485 7.3) for New Product Development.
  • Strong leadership, communication, and collaboration skills.
  • Ability to read and engineering drawings and test plans.
  • Strong technical writing skills and basic statistical knowledge.
  • Ability to handle multiple NPD and change management projects at one time.

Experience Required:

  • Educational background - BS required in technical field.
  • 3 + years manufacturing experience required
  • 3 + years in a quality engineering role required.
  • Medical device experience required, including knowledge of design controls per FDA 21 CFR 820.30 or ISO 13485 7.3
  • Experience in R&D and/or design engineering preferred, but not required.

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.

Information

We willconduct selection continuously so send us your application today

For information regarding Permobil‘s Privacy Notice, please visit privacy.permobil.com

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/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 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.

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