Process Engineer

Corin•Raynham, MA

9d•$85,000 - $95,000•Onsite

About The Position

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.

Requirements

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

Responsibilities

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