Material Reinvent Quality Engineer (Solventum)

Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear with us. In the interim, our Privacy Policy here: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ continues to apply to any personal information you submit, and the 3M-branded positions listed on our Careers Page are for Solventum positions. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Job Description:

Material Reinvent Quality Engineer (Solventum)

3M Health Care is now Solventum

At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.

We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.

The Impact You’ll Make in this Role

As a Material Reinvent Quality Engineer you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:

• Leading quality planning for critical material redesign or replacement projects for Solventum medical / combination devices and drug products.  Ensuring critical to quality attributes are defined and achieved throughout the projects while maintaining compliance to our quality management system.
• Defining and implementing test method validation, stability, and material design verification and validation strategies to satisfy design change controls and ensure and improve reliability and capability, while continuing to meet our customers’ expectations of product performance and quality. 
• Managing change through the lens of patient safety by assessing its impact on the products’ risk profile. Engaging cross-functional team to drive robust risk mitigations.
• Pursuing united goals with cross-functional global teams composed of members from R&D, manufacturing, regulatory, application engineering, business, clinical, and multiple other functions.

Your Skills and Expertise

To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:

• Bachelor’s Degree or higher (completed and verified prior to start) AND at least three (3) years of Medical Device, Pharmaceutical, or Combination Product experience in a Quality or Product Engineering or Design Assurance function in a private, public, government or military environment.

OR

• High School Diploma/GED (completed and verified prior to start) AND at least seven (7) years of Medical Device, Pharmaceutical, or Combination Product experience in a Quality or Product Engineering or Design Assurance function in a private, public, government or military environment.

Additional qualifications that could help you succeed even further in this role include:

• Master’s degree in Chemistry, Biology / Microbiology, Material Science, or related discipline from an accredited institution
• Scientific knowledge and experience in development of medical devices and relevant regulations and standards applicable to medical device compliance, such as ISO 13485 and ISO 14971
• American Society for Quality-ASQ™ certification such as Certified Quality Engineer (CQE)
• Six Sigma experience and/or certification related to the design and manufacture of new products
• Skills include, but are not limited to, Quality Engineering, Design Controls (including Design Verification), Process Validation, Risk Management, Test Method Validation, Critical to Quality (CTQ) Definition & Control, Critical Thinking, Statistical Data Analysis, Continuous Improvement, and The ability to navigate complexities and create solutions in highly technical and regulated environment

Work location: Hybrid in St. Paul, MN t