Risk Management III

Job Description

• 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.
  
  

Essential Duties And Responsibilities

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:

• Provide risk management 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 in compliance to ISO 14971 (2019) and IEC 62366 (2015)
  
  

QUALIFICATIONS/EXPERIENCE REQUIRED

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

• Bachelor’s Degree in Engineering (Mechanical, Systems, Chemical or Electrical) or Science (Mathematic, Chemistry).
• 5-7 years of experience of working within a medical device industry with subject matter expertise in the application of Risk Management (ISO 14971) to Class II and Class III medical devices
• Expertise in the application of Statistical Techniques to support Design of Experiments, Design Verification and Design Validation
• Expertise in DFSS techniques (Design Optimization and Characterization)
• Expertise in industry best practices and advances in Risk Management practices, process, tools and technology