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Mechanical Product Validation Engineer

Iconma

Blue Ash, OH

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JOB DETAILS
SKILLS
Analysis Skills, Cross-Functional, Design Failure Mode and Effects Analysis (DFMEA), Documentation, Feasibility Analysis, Hazard Analysis, Health Plan, Information Technology Consulting, Mechanical Engineering, Medical Equipment, Problem Solving Skills, Process Failure Mode and Effects Analysis (PFMEA), Product Development, Product Engineering, Product Testing, Product/Service Launch, Quality Assurance Methodology, Research & Development (R&D), Risk Management, Root Cause Analysis, Statistics, Sterilization, Technical Presentation, Technical Writing, Test Lab, Test Plan/Schedule, Testing, Time Management, Validation Documentation, Validation Testing
LOCATION
Blue Ash, OH
POSTED
4 days ago
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 considerationfor employment without regard to any status protected by applicable law.

About the Company

I

Iconma

ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.

  • Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
  • Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
  • Founded in 2000
  • 2000+ Employees

The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Management Consulting Services
EMPLOYEE BENEFITS
401K, Employee Referral Program, Life Insurance
FOUNDED
2000
WEBSITE
https://www.iconma.com/

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