What are the responsibilities and job description for the Risk Management SME ---- Cincinnati, OH position at Largeton Group?
RISK MANAGEMENT SME
Location; OH , local
GC, USC
Linkedin
JD::::
Location; OH , local
GC, USC
JD::::
- The job is a functional role in the Design and Reliability Assurance Engineering team at Integra Lifesciences, located in Cincinnati, OH.
- The role involves planning, organizing, leading, and reporting on all risk management activities in collaboration with cross functional teams.
- The individual will also lead and coordinate processes, practices, procedures, and technology adoption for continuous improvement in risk management deliverables for projects and programs.
- The role involves support of New Product Development (NPD), Sustaining Engineering, and Continuous Improvement projects of varying scope and complexity.
- The individual will collaborate with internal customers and external design and development partners, participating on cross-functional project teams through all phases of product and process development to commercialization.
- The role requires providing risk management leadership, expertise, guidance, and supervision during all project phases from initiation through end of life.
- It also involves leading the development and implementation of key performance indicators (KPIs) and metrics for the risk management process.
- The individual will conduct SWAT assessments in risk management to support continuous improvement across business processes.
- The job requires a Bachelor's Degree in Engineering (Mechanical, Systems, Chemical, or Electrical) or Science (Mathematics, Chemistry).
- The individual should have 5-7 years of experience in the medical device industry with expertise in Risk Management (ISO 14971) for Class II and Class III medical devices.
- The role requires expertise in the application of Statistical Techniques, DFSS techniques (Design Optimization and Characterization), and industry best practices and advances in Risk Management practices, process, tools, and technology.
