Skip to content
Senior Product Stewardship Specialist – Medsurg
| Company | Solventum |
|---|
| Location | Woodbury, MN, USA |
|---|
| Salary | $137439 – $167981 |
|---|
| Type | Full-Time |
|---|
| Degrees | Bachelor’s |
|---|
| Experience Level | Senior |
|---|
Requirements
- Bachelor’s Degree or higher AND seven (7) years of experience in product stewardship, biocompatibility, environmental sciences, quality, and/or technical field in a private, public, government, or military environment
- OR High School Diploma/GED AND (14) years of experience in product stewardship, biocompatibility, environmental sciences, quality, and/or technical field in a private, public, government, or military environment
Responsibilities
- Providing leadership for product stewardship within the Medical Surgical (MedSurg) business with functional ownership of a portfolio of medical devices, drugs, and other adjacent products.
- Leading and executing product stewardship activities to enable the business to meet its growth initiatives including driving materials compliance, assessment of safety to human health and the environment, liability avoidance, and other product stewardship topics.
- Develop and implement product stewardship strategies that contribute to the timely introduction of new and modified products.
- Facilitate product safety evaluations with subject matter experts, including partnering with toxicologists on biocompatibility data needs and test plans.
- Develop, implement, and execute processes to proactively guide development teams toward the use of favorable alternatives.
Preferred Qualifications
- Knowledge of the medical device industry and/or experience working with medical device quality management systems (e.g. ISO 13485)
- Experience in product biocompatibility testing and assessments, including knowledge of related standards, such as ISO 10993
- Experience supporting regulated products, such as those regulated by US FDA, EU MDR, and/or CE marked products.
- Global regulatory compliance experience in one or more of the following areas: regional and global chemical regulations including but not limited to TSCA, REACH, consumer product safety laws, hazard communication, and/or biocides
- Experience in product life cycle assessments, product risk assessments, and/or making risk-based decisions.
- Demonstrated leadership in process development, creative problem solving, project management, or lean six sigma experience
- Expert cross-functional collaboration skills with laboratory, quality, regulatory, marketing, and manufacturing functions and familiarity with their interdependencies
