Material Reinvent Senior Quality Engineer (Hybrid: Eagan, MN)

Solventum•Eagan, MN

18h•Hybrid

About The Position

Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers’ toughest challenges. As a Material Reinvent Senior 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. You will 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.

Requirements

Bachelor’s degree or higher (completed and verified prior to start)
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.
Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Nice To Haves

Experience and demonstrated scientific knowledge in the development of medical devices and in the application of regulations and standards relevant to medical device compliance, such as ISO 13485 and ISO 14971
Master’s degree in Chemistry, Biology/Microbiology, Materials Science, or a related discipline from an accredited institution
American Society for Quality (ASQ) certification, such as Certified Quality Engineer (CQE)
Experience and/or certification in Six Sigma methodologies related to the design and manufacture of new products
Experience applying quality engineering and product development practices, including Design Controls (such as Design Verification), Process Validation, Risk Management, Test Method Validation, Critical‑to‑Quality (CTQ) definition and control, statistical data analysis, and continuous improvement, within highly technical and regulated environments

Responsibilities

Leading quality planning for critical material redesign or replacement projects for Solventum medical / combination devices.
Ensuring critical to quality attributes are defined and achieved throughout the projects while maintaining compliance to our quality management system.
Defining and implementing test methods and test method validation, stability, process validation, updated risk management files, supplier assessments, 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, product stewardship, business, clinical, and various other functions.
Complying with corporate policies, procedures and security standards while performing assigned duties.