Manufacturing Engineer

Manufacturing Engineer Katalyst Healthcares & Life Sciences - 4.0 Pleasanton, CA Job Details Contract 1 day ago Qualifications Bachelor's degree in mechanical engineering Statistics Bachelor's degree in industrial engineering Quality control statistical data analysis Engineering Regulatory compliance Bachelor's degree in biomedical engineering Mechanical Engineering Configuration management Engineering process optimization Biomedical Engineering Quality management Mid-level 3 years Minitab Data management Industrial Engineering Performance Improvement (PI) Risk analysis FMEA Quality assurance within manufacturing Cross-functional collaboration Document management systems Data-driven decision making Manufacturing company experience Communication skills Process engineering Regulatory compliance management Cross-functional communication Statistical analysis tools

Full Job Description Job Summary:

Manufacturing Engineer with 3-4 years of experience in the medical device manufacturing industry, specializing in supporting regulated production environments. Experienced in manufacturing operations, process validation (IQ/OQ/PQ), configuration management, and continuous process improvement. Skilled in managing product data and documentation through PTC Windchill and MES systems while ensuring compliance with quality and regulatory standards. Strong background in cross-functional collaboration with manufacturing and quality teams to improve production efficiency and maintain robust documentation control.

Roles & Responsibilities:

Supported manufacturing engineering activities in a regulated medical device manufacturing environment Managed part creation, BOM development, updates, and configuration control using PTC Windchill Maintained and updated MES documentation and manufacturing procedures to ensure compliance and traceability Participated in process development and process characterization activities to improve manufacturing efficiency Executed and supported

IQ/OQ/PQ

validation activities for manufacturing processes and equipment Developed and maintained PFMEA (Process Failure Mode and Effects Analysis) to identify and mitigate process risks Performed statistical analysis using Minitab to support process improvement and data-driven decision-making Collaborated with cross-functional teams including manufacturing, quality, and R D to ensure smooth production workflows Supported continuous improvement initiatives to enhance product quality, yield, and operational efficiency Ensured adherence to regulatory requirements and internal quality management systems

Experience:

3-4 years of experience in medical device manufacturing or highly regulated manufacturing environments Hands-on experience with PTC Windchill for PLM and configuration management Experience working with MES (Manufacturing Execution Systems) and manufacturing documentation control Exposure to process validation activities including

IQ/OQ/PQ

Experience in PFMEA development and maintenance for risk analysis Working knowledge of statistical tools such as Minitab for process analysis and improvement Strong communication, teamwork, and cross-functional collaboration skills in regulated environments

Education:

Bachelor's degree in Mechanical, Industrial, Biomedical Engineering, or related field