3-4 years in medical device manufacturing or regulated environments
Hands-on experience with PTC Windchill for product lifecycle management
Familiarity with Manufacturing Execution Systems (MES)
Knowledge of process validation including IQ/OQ/PQ
Experience with PFMEA for risk assessment
Proficiency in statistical tools like Minitab
Strong communication and collaboration skills.
Responsibilities
Supported engineering activities in regulated medical device manufacturing
Managed BOM development and configuration control using PTC Windchill
Maintained MES documentation and manufacturing procedures
Participated in process development to enhance efficiency
Executed IQ/OQ/PQ validations for equipment and processes
Developed PFMEA to identify and mitigate risks
Conducted statistical analysis to support process improvements
Collaborated with teams across manufacturing, quality, and R&D
Led continuous improvement initiatives to enhance product quality and operational efficiency
Ensured compliance with regulatory requirements.
Benefits
Opportunity to work in a regulated industry with a direct impact on patient safety
Hands-on experience with advanced manufacturing systems and processes
Professional development opportunities in medical device manufacturing
Collaborative work environment with cross-functional teams
Focus on continuous improvement and innovation in processes.
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
