Senior Engr Quality

Job Description

Thank you for your interest in joining Solventum. 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.

While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy:  applies to any personal information you submit. 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.

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.

• Lead the development of process risk management per ISO 14971 for assigned projects.
• Provide quality engineering services for new and existing medical device products and feedback to product development and manufacturing.
• Lead failure investigations and problem resolution.
• Participates in and leads assigned project teams/tasks for the development and support of new and sustaining products and processes by providing quality engineering services to assigned projects with accountability for development, execution, and reporting of assigned activities for test method validation, design and process verification and validation, etc.
• Reviews and approves updates to quality system documents, quality system documentation, and labeling for new and existing products
• Mentors lower-level engineers in technical and professional development
• Reviews drawings to evaluate quality requirements including correct application of geometric dimensioning and tolerancing, proper use of engineering, process and material specifications, and identification of key characteristics for inspection plans and methods.
• Facilitates audit functions to support audits by governmental competent authorities (e.g., US Food and Drug Administration inspections), Notified Body audits, and internal/corporate audits;
  May participate in audits as a Technical subject matter expert.

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 in Engineering or Engineering Science and (3) years of experience as a Quality Engineer within a medical device organization in a private, public, government, or military environment.

In addition to the above requirements, the following are also required:

• 1 year of experience working under FDA regulations and recognized quality standards, including ISO 14971.

• Demonstrated experience conducting root cause investigations for medical device, biotechnology, and pharmaceutical products.
• Experience reviewing and approving process validation reports, as well as verification and validation activities.
• Proven ability to review and approve updates to Quality System documentation, Design History Files, and product labeling for new and existing products.

Hybrid Eligible (Job Duties allow for some remote…