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This is a key functional role within the Design and Reliability Assurance Engineering team. The role involves the process of planning, organizing, leading and reporting all risk management activities through collaboration with cross functional teams. This role is responsible to also lead and coordinate process, practice, procedures and technology adoption for the continuous improvement of risk management work product and deliverables for projects and programs.

The role is also responsible for support of New Product Development (NPD), Sustaining Engineering and Continuous Improvement projects of varying scope and complexity. This individual will collaborate with internal customers and external design and development partners, participating on cross-functional project teams through all phases of the product and process development through commercialization, and support technical teams with planning, execution, reporting and communication of Design and Reliability Assurance work products and deliverables.

Responsibilities

• Provide Risk Management and Human Factors leadership, expertise, guidance and supervision during all project phases from initiation through end of life.
• Development of efficient and robust processes, procedures, practice, tools and technology to support continuous improvement in risk management.
• Leads development and implementation of key performance indicators (KPI’s) and metrics for the risk management process and metrics.
• Leads and conducts SWAT assessments in risk management to support continuous improvement across business processes
Lead the process of planning, organizing, leading and reporting all risk management activities through collaboration with cross functional teams.
• Lead and support New Product Development (NPD), Sustaining Engineering and Continuous Improvement projects of varying scope and complexity.
• Collaborates with internal customers and external design and development partners, participating on cross-functional project teams through all phases of the product and process development through commercialization, and supports technical teams with planning, execution, reporting and communication of Design and Reliability Assurance work products and deliverables.

Qualifications

• Bachelor’s degree in engineering (Mechanical, Systems, Chemical or Electrical) or Science (Biology, Chemistry).
• 8 years of experience of 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.
• Strong analytical skills and a working knowledge of problem-solving methodologies
• Working knowledge of DFSS techniques
• 8 years of experience in a Quality Assurance role for medical device or pharmaceutical product development 
• Knowledge of industry best practices and advances in Risk Management practices, process, tools and technology
• Demonstrates excellent knowledge of statistical sampling and analysis tools/methods to support data-driven decision making
• Demonstrates excellent organizational, verbal and written communication skills • Proficient with the MS Office Suite, and statistical software.
• Must be able to work independently with minimal supervision.
• Able to prioritize projects and manage assigned Design Assurance resources to meet organizational goals and objectives