Mechanical Product Validation Engineer

Company : ICONMA, LLC

Our client, is a IT Services and Consulting company, is looking for a Mechanical Product Validation Engineer for their Blue Ash, OH location.
 
Responsibilities:

• Cleaning & Sterilization Validation, Test Method Development, product quality, DFMEA
• Develop soiling, cleaning and extraction processes for reusable scopes and instruments and accessories (I&A), incorporating real world use conditions and cleanability considerations.
• Plan, execute and analyze Cleaning and Sterilization (C&S) feasibility studies, cleanability assessments and sterilization validations for reusable scopes and I&A.
• Create and qualify test methods, perform Gage Repeatability & Reproducibility (GR&R) studies and document results in engineering studies, test protocols, reports and validation documentation, including statistical analysis as required.
• Conduct root cause analysis for C&S process issues and evaluation findings and communicate data driven solutions and recommendations to R&D and cross functional stakeholders.
• Support development and completion of associated risk management documentation (e.g., DFMEA, PFMEA, hazard analyses) by providing hands on laboratory expertise and technical input.
• Support Design Reviews and Phase Exit Reviews by preparing required documentation, developing presentation materials and presenting technical content related to cleaning, sterilization and reprocessing.
• Partner with internal teams and external supplier resources (e.g., test laboratories, sterilization vendors) to ensure timely completion of product development and launch deliverables.

 
Requirements:

• Mechanical Product Validation Engineer with hands on expertise in cleaning, sterilization and reprocessing validation for reusable medical devices.
• Experienced in developing test methods, executing C&S feasibility and validation studies, conducting GR&R and root cause analysis and supporting risk management and design reviews through cross functional collaboration.
• Years of Experience:   8.00 Years of Experience

Skills: 

• Category                                              Name                                                   Required                      Importance
• Areas of Expertise                                Validation                                            Yes                              1                     
• NA       Root Cause                               Analysis                                               Yes                              1

 
Why Should You Apply?

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities

 
ICONMA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to any status protected by applicable law.

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