Accellix is searching for a seasoned process engineer to join our operations team in our San Jose Location. This person will lead in the transfer of products from development to manufacturing by ensuring that all processes and equipment are installed and qualified for production to meet ISO13485 standards. This individual will operate as local production process and equipment subject matter expert.
Leads technology and product transfer efforts for new processes and product introduction from development to manufacturing
Leads risk assessments, verification and validation of product, equipment and processes
Develop and maintain the master validation plan and validation traceability matrix (“VTM”)
Develop and translate validation/user requirements into validation strategy in conjunction with development, quality, and operations organizations
Generate protocols and reports for design qualification, system verification, installation qualification, operational qualification, performance qualification
Executes validations and documents validation results in final reports
Perform data entry and statistical analysis of data collected during validation activities
Ensures that validations are documented using Good Documentation Practices and completed in compliance with ISO13485 Standards
Identify, procure, and install equipment to improve process and production capabilities
Modifies methodologies and procedures, ensuring continuous improvement
Train and support operators on new procedures, processes and changes
Provide process engineering support in quality system audits
Minimum 8 years of product development, process development, process engineering, manufacturing engineering, validation or product transfer with a Bachelor of Science in Engineering, Biotechnology, Chemistry, or Biology or Master’s degree with 4 years or PhD degree with 2 years
Experience in product development, process development, process engineering, manufacturing engineering, validation or product transfer in a medical device or invitro diagnostic reagent manufacturing environment.
Strong ability to plan, prioritize and manage complex and conflicting activities in a timely manner;
In-depth knowledge of ISO13485 requirements from development through commercialization of products
Work independently and on project teams
Attention to detail, perform critical analysis of situations and provide recommendations.