Design Assurance Engineer II

Working at Freudenberg: We will wow your world!

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.

Freudenberg Medical LLC