Sr. Manufacturing Engineer

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 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

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec's goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.