Senior Process Development Engineer

The Senior Process Development Engineer will formalize the company’s production processes and procedures and strive for continuous productivity and quality improvements/enhancements. This position will be crucial in driving continuous improvement initiatives, troubleshooting production issues, and collaborating with cross-functional teams. The person will be expected to fully understand all aspects of the device. We are looking for a team player who views medical device development as a competitive advantage.

• Maintain accurate and up-to-date documentation of production processes, changes and improvements
• Liaise with engineering to create and maintain current documentation of designs, tool drawings and work instructions
• Work with engineering on engineering change order implementation to ensure that all ECOs are closed in a timely manner
• Create process maps, PFMEAs, IQ OQ PQ, process implementation documentation, and create DHRs
• Develop manual assembly processes, assembly fixtures and test procedures and implement process improvements
• Troubleshoot assembly issues as they arise and implement corrective actions
• Drive creation of tests across electro-mechanical assemblies to assure sufficient quality before final assembly
• Review internal operational facility layouts for process improvement
• Establish and enforce quality control standards
• Implement corrective actions and preventive measures to enhance product quality
• Lead production implementation procedures across multiple departments and train operators on change processes
• Work with Quality Assurance to develop jigs and fixtures to accelerate the inspection process
• Ensure compliance with industry regulations and safety standards

• Minimum of Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering or related engineering field
• 10+ years experience working in a manufacturing/production environment with evidence of experience in manual assembly
• Strong knowledge of production processes, quality management, and continuous improvement methodologies
• Experience in reading electrical and wiring diagrams
• Proficiency in using production planning and ERP systems
• Solid knowledge of ISO standards
• Strong leadership, communication and collaboration skills
• Excellent analytical and problem-solving skills
• Strong passion for product and process excellence
• Six-sigma training preferred