Senior Sustaining Manufacturing Engineer

Cirtec Medical Corp.; Lowell (MA); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Healthcare benefits

401(k) plan

Paid time off

Job summary

Cirtec Medical Corp. in Lowell, MA, seeks a Senior Manufacturing Engineer – Sustaining to lead hands-on engineering for regulated medical-device manufacturing.

You will improve uptime, yield, and process capability through data-driven problem solving, SPC, and robust corrective actions. Collaborating with Operations, Quality, Maintenance, and Engineering, you will own processes, drive continuous improvement, and ensure compliance with GMP, ISO 13485, and FDA requirements.

Qualifications

• Bachelor’s degree in Engineering or related STEM field.
• Minimum of 5 years in manufacturing or process engineering in regulated environments.
• Hands-on experience supporting manufacturing processes and equipment.
• Experience with equipment qualification, process validation, and process controls.
• Strong analytical and problem‑solving skills including DOE and SPC.
• Experience with PFMEA, CAPA and NCR/NCMR processes.
• Ability to read engineering drawings and specifications.
• Excellent communication and cross‑functional collaboration.

Responsibilities

• Provide hands‑on engineering support for daily manufacturing operations.
• Lead investigations into defects and equipment failures to identify root causes.
• Develop metrics to improve uptime, efficiency, yield, and production performance.
• Implement data analysis, SPC, and visual management to monitor trends.
• Support new‑product introductions and manufacturing transfers.
• Ensure compliance with GMP, ISO 13485 and regulatory requirements.
• Mentor operators, technicians, and engineers to promote best practices.
• Create and maintain process documentation and work instructions.

Skills

Problem solving

Data analysis

Statistical analysis

DOE

Root cause analysis

Cross-functional collaboration

Project management

Written and verbal communication

Willingness to travel

Education

Bachelor's degree in Engineering

Tools

Minitab

CAD/SolidWorks

ERP/MES systems

QMS (document control)

Job description

Cirtec Medical Corp. in Lowell, MA, seeks a Senior Manufacturing Engineer – Sustaining to lead hands-on engineering for regulated medical-device manufacturing.

You will improve uptime, yield, and process capability through data-driven problem solving, SPC, and robust corrective actions. Collaborating with Operations, Quality, Maintenance, and Engineering, you will own processes, drive continuous improvement, and ensure compliance with GMP, ISO 13485, and FDA requirements.