Mechanical Product Validation Engineer

Mechanical Product Validation Engineer

Mechanical Product Validation Engineer with 5-10 years of experience in the medical device industry, specializing in cleaning, sterilization, and reprocessing validation for reusable medical devices. Responsible for planning and executing cleaning and sterilization feasibility studies, validation activities, test method development, and GR&R studies to ensure product safety, compliance, and performance. Experienced in root cause analysis, risk management (DFMEA/PFMEA), statistical data analysis, and technical documentation.

Proven ability to collaborate with R&D, Quality, Regulatory, and external partners to support product development, design reviews, and successful product launches in a regulated environment.

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.

Required Qualifications:

• B.E./B.Tech in Mechanical Engineering or equivalent with 5+ years of experience 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, including validation and documentation requirements.
• Strong technical writing, problem-solving, and communication skills with the ability to collaborate effectively across engineering, quality, and regulatory functions.

Belcan is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.