Process Engineer

Corin is seeking a Process Engineer for Technology to work in our Raynham, MA facility. This role will lead manufacturing process development, optimization, standardization, and maintenance within the Technology Manufacturing team at Corin. The role aims to achieve world-class performance through standardization and automation by improving and implementing end-to-end operational processes. The key responsibilities of the Process Engineer, Technology are/to: Develop, implement, and optimize best practices for technology based processes. Bring Technology based products from development to full scale manufacture. Creating, trialing and rolling out processes to production. Drive the implementation of new and optimized processes to ensure robust and repeatable operational improvements. Manage product and process changes with a focus on patient safety, operational safety, and device performance. Manage bill of materials to ensure all required assemblies and subcomponents are accurately accounted for and documented within Corin systems (Teamcenter/Sage) Perform process simulations and optimization tests. Lead Process Verification and Validation activities for when implementing new processes or technology in manufacturing. Use root cause analysis and Six Sigma methodologies to achieve best-in-class performance. Lead continuous improvement initiatives for Corin products and processes to support lean manufacturing and quality targets, such as Process Cycle Time Efficiency (PCE) and Corrective and Preventive Actions (CAPA) resolution. Responsible for process risk assessment documentation (PFMEA s) for technology based manufacture highlighting opportunities for lean projects Partner with and manage key service providers to optimize key equipment and line processes, aiming for process excellence. Partner with the Technology NPI team to support Design for Manufacture activities for new products and existing product improvements. Identify and integrate new process technologies to support continuous improvement and business growth. Create and maintain manufacturing, measurement, and technical documentation. Ensure compliance with Corin s

ISO13485

Quality Management System (QMS) and Good Manufacturing Practice (GMP)

FDA21 CFR

Part 820. The ideal Process Engineer, Technology will have/be:

Bachelor s degree in Mechanical/Electrical Engineering, Robotic Engineering or a related field Proven 2 to 5 years, experience in process design and implementation within a regulated environment, preferably Medical Devices Knowledge in developing standard operating procedures for optimized processes in regulated industries Competent in Electrical components and assembly in an operational environment Knowledge of Computer Aided Design (CAD) SolidWorks or Siemens NX Experience with project management and Lean, Six Sigma principles Analytical thinker with proven problem-solving abilities Familiarity with Health & Safety requirements and regulation Familiarity with

ISO13485

Quality Management System (QMS) and Good Manufacturing Practice (GMP)

FDA21 CFR

Part 820 Excellent communication and computer literacy Results-driven mindset The base pay range for this position is $85,000-95,000. The specific pay offered may be influenced by a variety of factors, including the candidate s experience, education, and skill set.