Bachelor's degree in Engineering or related STEM discipline required.
Minimum of 5 years of relevant manufacturing or process engineering experience.
Hands-on experience in a regulated manufacturing environment.
Proven track record of implementing sustainable improvements in manufacturing processes.
Strong analytical skills, including root cause analysis and statistical methods.
Experience with equipment qualification and process validation.
Knowledge of ISO 13485 and FDA Quality System requirements.
Responsibilities
Provide hands-on engineering support for daily manufacturing operations.
Collaborate with cross-functional teams to resolve technical issues and production risks.
Develop and monitor key performance metrics for manufacturing efficiency.
Implement data analysis and visual management systems for continuous improvement.
Establish process-control systems and corrective action plans.
Lead investigations into manufacturing defects and equipment failures.
Support new-product introductions and ensure process readiness.
Benefits
Opportunity for professional growth and development.
Collaborative work environment with cross-functional teams.
Engagement in continuous improvement initiatives.
Exposure to cutting-edge manufacturing technologies.
Potential for mentorship and training opportunities.
Full Job Description
Description
Position 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 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
About Cirtec Medical
Cirtec Medical is a medical device company that designs, develops, and manufactures implantable medical devices and components. The company's products are used in a variety of medical applications, including cardiovascular, orthopedic, and neurological procedures. Cirtec Medical was founded in 2014 and is headquartered in Irvine, California.
