Transforming lives. Fostering excellence.
This is a unique opportunity to make a meaningful impact on the future of healthcare. Embracing innovative thinking is at the heart of our approach. Every day, over 4,000 of us are pushing boundaries and driving progress to enhance outcomes.
This key functional role is part of the Design and Reliability Assurance Engineering team. The position involves coordinating risk management activities through collaboration with cross-functional teams, including planning, organizing, leading, and reporting.
The role also supports New Product Development (NPD), Sustaining Engineering, and Continuous Improvement projects of varying scope and complexity. This individual will work closely with internal customers and external design and development partners, participating on cross-functional project teams throughout all phases of product and process development through commercialization.
Responsibilities
1. Provide Risk Management and Human Factors leadership, expertise, guidance, and supervision during all project phases from initiation through end of life.
2. Develop efficient and robust processes, procedures, practices, tools, and technology to support continuous improvement in risk management.
3. Lead the development and implementation of key performance indicators (KPIs) and metrics for the risk management process and metrics.
4. Conduct SWAT assessments in risk management to support continuous improvement across business processes.
5. Lead the coordination of risk management activities through collaboration with cross-functional teams.
6. Support New Product Development (NPD), Sustaining Engineering, and Continuous Improvement projects of varying scope and complexity.
7. Collaborate with internal customers and external design and development partners, participating on cross-functional project teams throughout all phases of product and process development through commercialization.
Qualifications
1. Bachelor's degree in engineering (Mechanical, Systems, Chemical, or Electrical) or Science (Biology, Chemistry).
2. 8 years of experience working within a Medical device or other regulated industry with knowledge of Risk Management (ISO 14971:2019), MDD (Medical Device Directive), IEC 62366, ISO 13485 (Quality Management Systems), FDA QSR, and cGMP.
3. Strong analytical skills and working knowledge of problem-solving methodologies.
4. Working knowledge of DFSS techniques.
5. 8 years of experience in a Quality Assurance role for medical device or pharmaceutical product development.
6. Knowledge of industry best practices and advances in Risk Management practices, processes, tools, and technology.
7. Demonstrates excellent knowledge of statistical sampling and analysis tools/methods to support data-driven decision making.
8. Demonstrates excellent organizational, verbal, and written communication skills.
9. Proficient with the MS Office Suite and statistical software.
10. Able to work independently with minimal supervision.
11. Able to prioritize projects and manage assigned Design Assurance resources to meet organizational goals and objectives.