DescriptionPosition Summary:The Senior Manufacturing Engineer - Sustaining provides technical leadership and hands-on engineering support for manufacturing processes and equipment in a regulated medical-device environment. This role focuses on improving equipment uptime, production efficiency, process capability, and manufacturing yield through data-driven problem-solving, process optimization, and sustainable improvement systems. The position works cross-functionally with Operations, Quality, Maintenance, and Engineering to ensure manufacturing processes remain efficient, reliable, and compliant.
Key Responsibilities:- Provide hands-on engineering support for daily manufacturing operations, serving as the technical owner for assigned processes, products, and equipment.
- Partner with Operations, Quality, Maintenance, and Engineering to identify production risks, resolve technical issues, and drive timely corrective actions.
- Develop and monitor key performance metrics to improve equipment uptime, process efficiency, manufacturing yield, and overall production performance.
- Implement data analysis, process monitoring, and visual management systems to identify trends, minimize production losses, and support continuous improvement.
- Establish and maintain process-control systems, including critical process parameters, statistical process control (SPC), control limits, and corrective action plans.
- Lead investigations into manufacturing defects, equipment failures, yield losses, nonconforming materials, and customer complaints to identify root causes and implement sustainable solutions.
- Apply statistical analysis, Design of Experiments (DOE), 5-Why analysis, fishbone diagrams, and other problem-solving methodologies to improve process capability and reliability.
- Utilize PFMEA, hazard analysis, and risk-management tools to identify potential manufacturing failures and implement preventive controls.
- Develop, optimize, and maintain manufacturing processes, tooling, fixtures, operating parameters, and inspection methods.
- Create and update engineering change orders, work instructions, technical specifications, drawings, and manufacturing documentation.
- Lead continuous-improvement initiatives focused on safety, quality, productivity, throughput, material utilization, and cost reduction.
- Evaluate new equipment, tooling, and manufacturing technologies, including equipment qualification, process validation, and return-on-investment analysis.
- Support new-product introductions and manufacturing transfers by ensuring process readiness, production capacity, documentation, training, and quality requirements.
- Provide technical training, mentorship, and guidance to operators, technicians, and engineers to promote consistent manufacturing practices.
- Ensure compliance with company quality systems, safety policies, regulatory requirements, and standard operating procedures.
Must Have:- Bachelor's degree in Engineering or a related STEM discipline is required.
- Minimum of 5 years of relevant manufacturing or process engineering experience, or an equivalent combination of education and relevant professional experience.
- Hands-on experience supporting manufacturing processes and equipment in a regulated manufacturing environment.
- Demonstrated ability to develop and implement sustainable improvements in equipment uptime, production efficiency, process capability, and manufacturing yield.
- Strong analytical and problem-solving skills, including root cause analysis, statistical analysis, Design of Experiments (DOE), and process optimization.
- Experience establishing performance metrics, analyzing manufacturing data, identifying trends, and implementing measurable improvements.
- Experience with equipment qualification, process validation, and manufacturing process controls.
- Working knowledge of PFMEA, NCR/NCMR, CAPA, complaint investigations, engineering change control, and document control.
- Ability to read and interpret engineering drawings, technical specifications, manufacturing procedures, and inspection requirements.
- Strong project management and organizational skills, with the ability to manage multiple priorities and respond to urgent production needs.
- Excellent written and verbal communication skills and the ability to collaborate effectively with cross-functional teams.
- Ability to lead, train, and mentor manufacturing personnel while maintaining high quality and compliance standards.
- Proficiency in Microsoft Office applications.
- Knowledge of ISO 13485, FDA Quality System requirements, and Good Manufacturing Practices (GMP).
- Willingness to travel occasionally, generally less than 5%.
Good to Have:- Experience in medical-device manufacturing or continuous-flow manufacturing environments.
- Experience developing manufacturing dashboards, visual management systems, and production performance reporting tools.
- Familiarity with Minitab or other statistical analysis software.
- Experience with CAD/SolidWorks, ERP/MES systems, or electronic quality management systems.
- Knowledge of Lean Manufacturing, Six Sigma, and other continuous-improvement methodologies.
- Experience evaluating, implementing, and optimizing manufacturing equipment, tooling, and automation technologies.
- Experience supporting new-product introductions, manufacturing transfers, and production scale-up activities.
Salary Range: $100,000 to 130,000
