Senior Manufacturing Process Engineer

About the position

We are seeking a highly skilled Injection Molding and Automation Process Engineer to lead and optimize manufacturing processes for injection molding, assembly, and automation systems. This role requires extensive experience in validation activities, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification), and the ability to implement and troubleshoot automated manufacturing solutions. The successful candidate will ensure that all systems and processes meet stringent quality, regulatory, and production efficiency standards.

Responsibilities

• Maintain safe work practices.
• Provide 'hands-on' technical support for operations and operators to facilitate knowledge multiplication, problem resolution, standard work, and best practices.
• Provide Scientific Molding Analysis by identifying optimal conditions by evaluating factors such as material temperature, flow rate, pressure, and cooling rate during molding process and most important during the development of molding process.
• Lead the creation and execution of IQ, OQ, and PQ protocols and reports for injection molding, assembly, and automation equipment.
• Analyze validation data to confirm that processes meet regulatory and customer requirements.
• Develop validation documentation and lead activities of Process Technicians in support of assigned projects and new product introductions.
• Design, implement, and optimize automation solutions for manufacturing, including vision systems, robotic systems, assembly lines, and automated inspection equipment.
• Manage the scrap reduction program and oversee the daily implementation and monitoring of the EDart system.
• Collaborate with team members to troubleshoot molding machine issues and conduct Non-Conformance Report (NCR) investigations as needed.
• Develop and implement new fixtures, manufacturing processes, techniques, process improvements and cost reductions.
• Perform data analysis and/or write progress reports on existing manufacturing processes to ensure performance is within expectations.
• Troubleshoot and maintain automated systems to ensure continuous production flow and minimize downtime.
• Lead the integration of automated equipment into existing production systems while ensuring compatibility and compliance with safety and regulatory requirements.
• Partner with cross-functional teams to drive innovation in automation and manufacturing technologies.
• Support new process implementation and current production process improvement/optimization.
• Monitor assembly operations, tracking efficiency and potential issues where assigned.
• Identify and analyze flows, layout, and workplaces.
• Conduct root cause analysis of failure modes, solving equipment and process issues.
• Manage project timelines and contribute to project budgets.
• Perform other duties as assigned.

Requirements

• 5+ years' experience in a medium/high volume manufacturing environment (injection molding, assembly, etc.)
• Knowledge of statistical techniques (design of experiments, measurement R&R, and statistical process control).
• Working knowledge of machining, tools, fixturing, and assembly practices.
• Knowledge and experience of subassembly and assembly operations of plastic molded and metal parts.
• Knowledge and working experience with mechanical (indicators, micrometers, etc.) and electronic metrology instrumentation (CMM, Interferometer, Confocal microscope, etc.) is preferred.
• Excellent interpersonal and verbal/written communication skills.
• Advanced PC skills with standard MS Office software.
• Knowledge and experience in secondary processes, i.e. ultrasonic welding, UV curing, pad printing, laser printing preferred.
• Knowledge and experience of manufacturing engineering in medical device industry preferred.

Nice-to-haves

• Mechanical or Manufacturing Engineering preferred.

Benefits

• Equal employment opportunities (EEO) to all employees and applicants for employment.