DescriptionThis role is for the second shift - Monday-Thursday- 3:30pm-1:30amPosition Summary: The Senior Sustaining Engineer (2nd shift) provides hands-on engineering support for the manufacturing of medical device components, with primary responsibility for supporting 2nd shift production operations. Working primarily on the manufacturing floor, this role serves as the technical lead for assigned production lines, ensuring process stability, resolving manufacturing issues, implementing corrective actions, and driving continuous improvement
This role collaborates cross-functionally to meet production and quality objectives within a contract manufacturing environment.
Key Responsibilities:- Provide daily hands-on engineering support to manufacturing operations, with primary responsibility for supporting 2nd shift production activities. Serve as the primary engineering point of contact for assigned production lines, troubleshooting manufacturing and product issues, performing root cause analysis, implementing corrective and preventive actions, and partnering with Production, Quality, Maintenance, and Supply Chain teams to rapidly escalate and resolve issues, minimize downtime, and drive operational excellence through adherence to quality standards, single-piece flow principles, waste reduction, and continuous improvement.
- Own and maintain manufacturing processes, including work instructions, process documentation, and standard operating procedures for assigned product lines.
- Track and analyze manufacturing performance metrics such as yield, scrap, and process efficiency, and support reporting to management and customers.
- Identify and implement process improvements to increase yield and improve overall efficiency.
- Support urgent production needs by prioritizing and executing engineering tasks in alignment with business and customer requirements.
- Support quality systems by participating in CAPA investigations, non-conforming material reviews, and customer complaint resolution.
- Ensure all manufacturing processes and documentation comply with company quality systems and applicable regulatory requirements.
- Provide technical guidance and mentorship to junior engineers and train manufacturing operators on best practices, process requirements, quality standards, and standard work procedures to support workforce development, process consistency, and knowledge sharing.
Must Have:- Bachelor's degree in a STEM engineering discipline required.
- Minimum of 5 years of experience in medical device manufacturing or a regulated industry.
- Strong experience in sustaining engineering, manufacturing support, and process troubleshooting, with a proven track record of floor-based production support, rapid problem-solving, cross-functional collaboration, and execution in a high-volume manufacturing environment.
- Demonstrated ability to perform root cause analysis and implement effective corrective actions.
- Working knowledge of ISO 13485 and GMP requirements.
- Experience with manufacturing process documentation and engineering change management.
- CAD experience required (e.g., SolidWorks or similar).
- Strong verbal and written communication skills.
- Strong problem-solving skills with a hands-on, detail-oriented approach.
- Experience with MES and ERP systems required.
Good to have:- Experience with Lean manufacturing principles and continuous improvement methodologies; Six Sigma certification a plus.
- Experience with single-piece flow manufacturing is a plus.
Salary Range: $100,000 to 135,000 based on skills and experience
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.
