Material Reinvent Senior Quality Engineer; Hybrid: Eagan, MN

Job Description

Material Reinvent Senior Quality Engineer

3M Health Care is now Solventum.

• Lead quality planning for critical material redesign or replacement projects for Solventum medical / combination devices. Define and achieve critical-to-quality attributes throughout projects while maintaining compliance with the quality management system.
• Define and implement test methods, 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 improve reliability and capability.
• Manage change from a patient‑safety perspective by assessing its impact on the product risk profile and engaging cross‑functional teams to drive robust risk mitigations.
• Collaborate with global cross‑functional teams from R&D, manufacturing, regulatory, product stewardship, business, clinical, and other functions to pursue united goals.

Minimum qualifications:

• 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.

Additional qualifications that could help:

• Experience and scientific knowledge in the development of medical devices and in applying regulations and standards 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 design and manufacture of new products.
• Experience applying quality engineering and product development practices—Design Controls, Process Validation, Risk Management, Test Method Validation, CTQ definition and control, statistical data analysis, and continuous improvement—in highly technical and regulated environments.

Work location:

Hybrid Eligible (remote work with some travel to Eagan, MN).

Travel:
May include up to 20% domestic/international.

Relocation Assistance:
May be authorized.

Must be legally authorized to work in the country of employment without sponsorship for employment visa status (e.g., H1B).

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.

Additional benefits include:
Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences, and Retirement Benefits.

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.

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