REMOTE - Senior Design Assurance Engineer

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Imagine a job where you will have the opportunity to do exciting and challenging work while collaborating with extraordinary colleagues. A company that invests in you and your career, providing the training, mentoring, development, and support you need to be successful now and in the future. If you want a career without limits with a broadly diversified and globally leading family-owned technology company where you can make an impact, then imagine an opportunity at Heraeus. Every day, our worldwide team of around 17,200 employees brings forward new ideas and solutions that are impacting and transforming everything from healthcare and renewable energy to e-mobility, high-tech, and telecommunications.

   

Engineered Tissue Solutions was acquired in 2021 by the Heraeus Group, a FORTUNE Global 500 listed and broadly diversified family-owned technology company. Learn more about Heraeus Group at www.heraeus.com.

 

ALTHOUGH A REMOTE ROLE, THIS POSITION MUST RESIDE IN MINNEAPOLIS/ST PAUL AREA

 

The following challenges await you:

•    Lead, own, create and update the design history file (DHF) including user requirements, design specifications, design verification and validation activities, test protocols and reports, and manufacturing process implementation.
•    Lead and implement product development projects and change requests for new products, line extensions, quality improvement initiatives, manufacturing updates, and new supplier qualifications.
•    Responsible for Risk Management activities from product concept through commercialization.
•    Coach and mentor the development and commercial team on design control activities.
•    Partner with regulatory to support and create content for US regulatory submissions for 510k clearance and pre-market authorizations.
•    Work with contract research organizations and test facilities to develop and execute pre-clinical and c