Design Assurance Engineer II

Working at Freudenberg: "We will wow your world!" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 52,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.

At Freudenberg Medical, we make products that save and improve the lives of people every day, all around the world. We are a global provider for medical device design and manufacturing with more than 2,500 employees. Innovation is at the core of our company, and we are proud of our industry-leading quality, lean manufacturing, and focus on innovation in products and processing technologies. Freudenberg Medical is an exciting place to work with lots of opportunity to learn, develop, and grow your career. Come join us and together we can make a difference in the future of healthcare.

Some of your Benefits

401K Match: Save for retirement with the company's help.

Personal Development: We offer a variety of trainings to ensure you can develop in your career.

Diversity & Inclusion: We focus on providing an inclusive environment and recognize our diversity contributes to our success.

Corporate Events: We celebrate success as a team, because only together can we achieve our goals.

Sustainability & Social Commitment: We support social and sustainable projects and encourage employee involvement.

No Visa Sponsorship Available

Minnetonka, MN

On-Site

Freudenberg Medical LLC

payments $75,000 - $95,000 per year

You support our team as

Design Assurance Engineer II

Responsibilities

• Work collaboratively with engineers and other personnel assigned to the product development project team.
• Develop, maintain, execute, and control Component Validation Plans and external supplier qualifications during the product development lifecycle.
• Initiate and lead the resolution of non-conformances / CAPAs.
• Lead the creation and execution of test methods and test method validation plans in support of component, design, and process verification activities.
• Analyze test data using statistical tools, perform in-depth interpretation of results, and generate detailed technical reports.
• Provide support to project teams in the compliance of ISO13485, MDD / MDR, QSR, JPAL, and any other applicable standards or requirements.
• Facilitate client personnel in performance of quality systems audits related to a particular project.
• Create and maintain quality records for DHFs in accordance with FDA QSR and/or other regulatory requirements.
• Support or lead design verification / validation activities including protocol and report writing.
• Collaborate on process characterization, experimentation, optimization and qualifications.
• Represent design assurance engineering interests in communications with clients and suppliers.
• Participate as a member of a project team in support of one or more product development programs.
• As appropriate, provide coaching and guidance regarding project tasks to other associates.
  
  

Qualifications

• 4 years technical degree, or equivalent experience
• Minimum of 3 years related work experience, preferable in a medical device area, or equivalent.
• 3 – 7 years’ experience in Quality Engineering
• M.S. degree may account for 2 years' experience.
• Experienced in quality systems (ISO13485, ISO9000 and/or QSR)
• CQE, CQA (ratings), preferred
• Ability to work extended hours as required
• Close visual acuity to perform activity exp. Small parts, operation of machines, viewing a computer
  
  

The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.