Process Validation Engineer in Columbia City

Job DescriptionJob Description

• Perform verification and validation testing activities on processes used in medical device manufacturing
• Aid in the establishment of new processes and the parameters associated with the processes
• Compose documentation for each phase of validation
• Aid in the establishment and maintenance of work instructions for validated processes
• Provide evidence of the consistency/repeatability for processes through testing of parameters
• Adapt processes to meet new requirements, standards, and/or criteria
• Monitor the control of validated processes
• Maintain the Material Contacts list for the facility
• Conduct DOE studies to develop parameters for validated processes
• Research and provide input on new processes and technologies
• Develop and execute Design of Experiments
• Develop validation protocols and perform testing
• Troubleshoot complex validation issues and apply advanced validation engineering and scientific principles to the design and implementation of process modifications

Education and/or Experience

• Associates degree in manufacturing or quality engineering, or equivalent experience, required. A four-year degree is .
• Experience in a manufacturing environment required
• ISO 13485 experience

Knowledge, Skills, & Abilities

• Knowledge of basic validation principles
• Strong written and verbal communication skills
• Good problem solving skills
• Ability to adapt to workload and work independently
• Strong attention to detail
• Ability to operate office equipment, including computers, copiers, fax machines, and phones

Environmental & Physical Demands

• Manufacturing environment. May require sitting or standing for long periods of time
• Occasional exposure to loud noise
• May require long periods of time in front of a computer

Company DescriptionMicropulse is a medical device manufacturer in Columbia City, IN, specializing in surgical instruments, implants, cases and trays and sterilization and packaging.Company DescriptionMicropulse is a medical device manufacturer in Columbia City, IN, specializing in surgical instruments, implants, cases and trays and sterilization and packaging.