Sr. Sustaining Engineer (2nd Shift)

Cirtec Medical; Lowell (MA); On-site; USD 100,000 - 135,000; Full time

Job summary

Cirtec Medical in Lowell, MA, seeks a Senior Sustaining Engineer (2nd shift) to provide hands-on manufacturing support for medical device components. You will lead technical activities on assigned production lines, resolve issues, and drive continuous improvement on the floor.

This role requires 5+ years in regulated medical device manufacturing, strong root-cause analysis, ISO 13485/GMP knowledge, and CAD skills (SolidWorks).

Qualifications

• Bachelor's degree in a STEM engineering discipline.
• 5+ years in medical device manufacturing or a regulated industry.
• Experience in sustaining engineering and floor-based production support.
• Root cause analysis and corrective actions.
• Working knowledge of ISO 13485 and GMP requirements.
• CAD experience (e.g., SolidWorks).
• Experience with MES and ERP systems.
• Lean manufacturing and Six Sigma a plus.
• Single-piece flow manufacturing a plus.

Responsibilities

• Provide hands-on engineering support to 2nd shift manufacturing lines; troubleshoot issues; drive continuous improvement.
• Own and maintain manufacturing processes, work instructions, process docs and SOPs for assigned lines.
• Track and analyze yield, scrap, and process efficiency; report metrics to management and customers.
• Identify and implement process improvements to increase yield and efficiency.
• Support CAPA investigations and quality system activities (non-conformances, customer complaints).
• Mentor junior engineers and train operators on best practices and standard work.

Skills

Sustaining engineering

Root cause analysis

Cross-functional collaboration

Problem solving

Quality systems

Education

Bachelor's degree in STEM

Tools

SolidWorks

MES

ERP systems

Job description

Description

This role is for the second shift - Monday-Thursday- 3:30pm-1:30am

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 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 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

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.