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Manufacturing Engineer

Karwell Technologies

Pleasanton, CA

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JOB DETAILS
SKILLS
Bill of Materials (BOM), Biomedical Engineering, Change Control, Communication Skills, Configuration Management, Continuous Improvement, Cross-Functional, Data Management, Data Processing, Documentation, Industrial Engineering, Maintain Compliance, Manufacturing, Manufacturing Engineering, Manufacturing Execution Systems (MES), Manufacturing Operations, Manufacturing Systems, Manufacturing/Industrial Processes, Medical Equipment, Minitab, Operations Processes, Process Analysis, Process Development, Process Failure Mode and Effects Analysis (PFMEA), Process Improvement, Process Validation, Product Documentation, Product Management, Product Programs, Production Support, Production Systems, Quality Management, Regulatory Compliance, Regulatory Requirements, Research & Development (R&D), Risk Analysis, Risk Management, Statistics, Team Player, Traceability, Windchill PLM Software
LOCATION
Pleasanton, CA
POSTED
17 days ago
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

About the Company

K

Karwell Technologies

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