Mechanical Product validation Engineer
Apolis
Job Title: Mechanical Product Validation Engineer Location: Cincinnati, OH (Onsite) Tax Term: W2 Job Type: Contract Duration: Long-Term Job Description: 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. Roles & 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.
- Cleaning & Sterilization Validation
- Cleaning & Sterilization (C&S) Feasibility Studies
- Reprocessing Validation
- Test Method Development
- Cleanability Assessment
- Sterilization Validation
- Gage Repeatability & Reproducibility (GR&R)
- Root Cause Analysis
- Product Quality
- DFMEA
- PFMEA
- Hazard Analysis
- Risk Management
- Medical Devices
- Reusable Scopes
- Instruments & Accessories (I&A)
- Engineering Studies
- Validation Documentation
- Statistical Analysis
- Design Reviews
- Phase Exit Reviews
- Cross-Functional Collaboration
- B.E. in Mechanical Engineering or equivalent.
- 5-10 years of relevant experience.
- Hands-on experience with cleaning, sterilization, and reprocessing validation for reusable medical devices.
- Experience developing and qualifying test methods and conducting GR&R studies.
- Strong experience with root cause analysis and product quality.
- Experience supporting DFMEA, PFMEA, hazard analysis, and other risk management activities.
- Experience collaborating with R&D, quality, engineering, suppliers, test laboratories, and sterilization vendors.
- Strong technical documentation, analytical, and communication skills.
Vacancy posted 2 days ago
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Apolis
Cincinnati, OH3 days ago
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