Validation Mechanical Engineer
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Job Summary
Mechanical Product Validation Engineer with 5-10 years of experience in the medical device industry specializing in cleaning sterilization and reprocessing validation of reusable medical devices. Skilled in feasibility studies validation protocols test method development GR&R risk management (DFMEA/PFMEA) statistical analysis and root cause investigations. Experienced in cross-functional collaboration to support compliant product development and successful product launches.
Responsibilities
Required Qualifications
- B.E./B.Tech in Mechanical Engineering or equivalent with 5-10 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 product 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.
- Develop soiling cleaning and extraction processes for reusable scopes and instruments and accessories (I&A) incorporating real world use conditions and cleanability considerations.
Job Responsibilities
- 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.
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