Senior Sustaining Engineer

About the role

Provide hands-on support for medical device component manufacturing.

As technical lead for assigned lines, stabilize processes, resolve production issues, implement corrective actions, and drive continuous improvement with Production, Quality, Maintenance, and Supply Chain.

Tasks

• Provide daily floor-based engineering support and serve as the primary engineering contact for assigned lines.
• Troubleshoot product and process issues; conduct root cause analysis and implement corrective and preventive actions.
• Partner across functions to minimize downtime, meet quality and production goals, and improve yield, scrap, flow, and efficiency.
• Own manufacturing processes, work instructions, SOPs, engineering changes, and related documentation.
• Support CAPA investigations, nonconforming material reviews, customer complaints, metrics reporting, and regulatory compliance.
• Prioritize urgent production needs; mentor junior engineers and train operators on process, quality, and standard work.

Requirements

• Bachelor’s degree in a STEM engineering discipline and 5+ years in medical device manufacturing or another regulated industry.
• Strong sustaining engineering, high-volume manufacturing support, troubleshooting, root cause analysis, and cross-functional problem-solving experience.
• Working knowledge of ISO 13485, GMP, process documentation, and engineering change management.
• Experience with CAD (such as SolidWorks), MES, and ERP systems.
• Strong written and verbal communication skills with a hands-on, detail-oriented approach.
• Preferred: Lean manufacturing, continuous improvement, Six Sigma certification, and single-piece flow experience.

Schedule

• Monday–Thursday, 2:00 p.m.–12:00 a.m.
• Full-time/direct hire

Pay

• $100,000–$135,000, based on skills and experience

How to apply

• Apply now.
• Send your resume

Location

• Boston, MA area