Trident Consulting is seeking a "Mechanical Engineer" for one of our clients in "Cincinnati, OH" A global leader in business and technology services.
Role: Mechanical product Validation Engineer
Location: Cincinnati, OH
Job Type: Contract – W2
Must Have's:
- Cleaning & Sterilization Validation, Test Method Development, product quality, DFMEA
Job summary:
- 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.
Responsibilities:
- 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.
About Trident Consulting
Trident Consulting is an award-winning staffing and consulting firm headquartered in San Ramon, CA. Since 2005, we’ve partnered with Fortune 500 and high-growth companies to deliver high-quality talent across technology, engineering, business operations, and professional services.
We specialize in contract, contract-to-hire, and direct hire placements, supporting roles across IT, data & analytics, cloud, cybersecurity, finance & accounting, HR, operations, and more. With a strong focus on hard-to-fill and niche positions, our global recruiting engine enables us to deliver speed, quality, and scale.