Material Reinvent Senior Quality Engineer; Hybrid: Eagan, MN

Material Reinvent Senior Quality Engineer

Solventum is a new healthcare company with a legacy of solving big challenges that improve lives and help healthcare professionals perform at their best.

As it was with 3M, 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.

The Impact You'll Make in this Role:

• Lead quality planning for critical material redesign or replacement projects for Solventum medical / combination devices. Ensure critical to quality attributes are defined and achieved throughout the projects while maintaining compliance with our quality management system.
• Define and implement test methods and 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.
• Manage change through the lens of patient safety by assessing its impact on the products' risk profile. Engage cross-functional team to drive robust risk mitigations.
• Pursue united goals with cross-functional global teams composed of members from R&D, manufacturing, regulatory, product stewardship, business, clinical, and various other functions.

Your Skills And Expertise:

• Bachelor's degree or higher (completed and verified prior to start) AND 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.
• 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.

Work location:

Hybrid Eligible. Job duties allow some remote work but require travel to Eagan, MN.

Travel:
May include up to 20% domestic or international travel.

Relocation assistance may be authorized.

Must be legally authorized to work in country of employment without sponsorship for employment visa status.

Supporting Your Well-being:

Solventum offers many programs to help you live your best life - both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.

Applicable to US applicants only:
The expected compensation range for this position is $106,000 - $145,750, which includes base pay plus variable incentive pay if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate's relevant knowledge, training, skills, work location, and or experience. In addition, this position may be eligible for a range of benefits (Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.).

Responsibilities of this position include compliance with corporate policies, procedures, and security standards while performing assigned duties.

Solventum is an equal opportunity employer. Solventum will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.