Sr. Manufacturing Engineer

Cirtec Medical

Lowell, MA

Pay: $100,000-$130,000/yr

Shift: Full time

**Description**

**About us:**

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.

Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!

**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 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