Demo

Risk Management III

Aditi Consulting
Cincinnati, OH Full Time
POSTED ON 3/5/2025
AVAILABLE BEFORE 6/4/2025

Payrate : $70.00 - $95.00 / Hour

Summary :

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 :

  • 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 :

  • 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 Valiation
  • Expertise in DFSS techniques (Design Optimization and Characterization)
  • Expertise in industry best practices and advances in Risk Management practices, process, tools and technology
  • Pay Transparency : The typical base pay for this role across the U.S. is : $70.00 - $95.00 per hour. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.

    For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy (https : / / www.aditiconsulting.com / privacy-policy).

    Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying to this position, you agree to Aditi's use of AI technology including calls from an AI Voice Recruiter.

    AditiConsulting

    Salary : $70 - $95

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