• Consult with the primary engineering owner for released products to understand the design intent
• Troubleshoot product, manufacturing, and field issues and implement solutions
• Lead root cause analysis (RCA) and corrective/preventive actions (CAPA)
• Initiate and execute engineering changes (ECOs) as required for design changes and follow existing product development processes in the concept, design, testing and implementation of product improvements
• Update drawings, BOMs, specifications, and assist with work instructions updates where needed
• Support suppliers and contract manufacturers as well as working alongside the quality department to resolve quality or supply issues
• Identify and implement cost reduction and product optimization opportunities (including, but not limited to, leveraging off the shelf solutions first in determining product optimization solutions)
• Monitor product performance and drive continuous improvement initiatives (and collaborate with Product Management)
• Support validation, verification, and testing as needed for changes
• Ensure proper documentation and adherence to quality systems (e.g., cGMP, ISO)
• Provide technical support to internal teams (Operations, Quality, Commercial, Marketing)
• Assist with revalidation activities as required
• Communicate with cross functional teams of projectís status
• Ensure that project learnings are integrated into future design plannings and executions