REMOTE - Senior Design Assurance Engineer

REMOTE - Senior Design Assurance Engineer

Location Minneapolis/St. Paul 

Permanent  

Full Time

 

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 clinical test plans. 
•    Work closely with contract manufacturers and other suppliers to implement new projects and ensure supply chain meets performance and quality requirements.

Your Profile:

•    Bachelor’s or advanced degree in engineering or related science, materials research, engineering or related field.
•    8+ years experience in product engineering, project management, quality assurance and/or regulatory positions in a medical device company, including direct experience with the development process and DHF as described in the job requirements.
•    Experience in a small company or start-up environment.
•    Strong understanding and experience with product development and quality requirements under ISO 13485 and 21 CFR 820, GMP and FDA 510k and PMA pathways.
•    Hands-on and versatile mindset required to succeed in a small company or start-up environment.
•    Effective and efficient in a remote or hybrid work environment and working with associates across the US and Europe.
•    Competent and efficient technical writing skills.
•    Demonstrate discretion, confidentiality, and professionalism when representing the company.

Diversity is at the core of our Vision, Mission, and Values. Heraeus is committed to an inclusive workforce that fully represents many different cultures, backgrounds and viewpoints. We can provide you with the opportunity - and Open Space - where your ideas and career can grow and advance. A career with Heraeus offers attractive compensation, top-notch benefits, and an ideal environment that supports your professional development.

In case of any questions, our HR team is available at hrdirect-americas@heraeus.com. You can also find more information at www.heraeus.com/careersusa.

 

 

Keywords: Design Assurance Engineer, Quality Engineer, Wound care