Sr. Mechanical Engineer

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 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.

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.