Medical Device Cleaning & Sterilization Validation Engineer

Belcan Corporation; Cincinnati (OH); On-site; USD 69,000 - 83,000; Part time

Job summary

Belcan Corporation seeks a Mechanical Product Validation Engineer with 5–10 years of medical device experience, focusing on cleaning, sterilization, and reprocessing validation for reusable devices. You will plan and execute feasibility studies, develop test methods, and conduct GR&R analyses to ensure safety, compliance, and performance.

You will collaborate with R&D, Quality, Regulatory, and external partners to support product development, design reviews, and launches in a regulated

Qualifications

• B.E./B.Tech in Mechanical Engineering or equivalent with 5+ years in the medical device industry.
• Hands-on expertise in cleaning, sterilization, and reprocessing validation for reusable medical devices.
• Proven experience in developing and validating cleaning and sterilization test methods, including feasibility studies and validation protocols.
• Strong knowledge of validation methodologies, including GR&R studies, root cause analysis, and statistical data evaluation.
• Experience supporting risk management activities, design reviews, and cross-functional project teams throughout the product development lifecycle.
• Familiarity with applicable regulatory and industry standards for reusable medical devices.
• Strong technical writing, problem-solving, and communication skills across engineering, quality, and regulatory functions.

Responsibilities

• Develop soiling, cleaning and extraction processes for reusable scopes and instruments and accessories, considering real-world use conditions.
• Plan, execute and analyze Cleaning and Sterilization feasibility studies and validation for reusable scopes and I&A.
• Create and qualify test methods, perform GR&R studies and document results with statistics and validation reports.
• Conduct root cause analysis for C&S issues and communicate data-driven solutions to R&D and stakeholders.
• Support risk management documentation (DFMEA/PFMEA) with hands-on lab input.
• Assist Design Reviews and Phase Exit Reviews by preparing documentation and presenting technical content.
• Coordinate with internal teams and external labs/vendors to ensure timely completion of development and launch deliverables.

Skills

Mechanical engineering

Validation methods

GR&R studies

Statistical analysis

Technical writing

Cross-functional collaboration

Education

B.E./B.Tech in Mechanical Eng

Job description

Belcan Corporation seeks a Mechanical Product Validation Engineer with 5–10 years of medical device experience, focusing on cleaning, sterilization, and reprocessing validation for reusable devices. You will plan and execute feasibility studies, develop test methods, and conduct GR&R analyses to ensure safety, compliance, and performance.

You will collaborate with R&D, Quality, Regulatory, and external partners to support product development, design reviews, and launches in a regulated