Manufacturing Engineer

MANIFEST Technology; Boston (MA); On-site; USD 100,000 - 135,000; Full time

Job summary

MANIFEST Technology is seeking a Senior Sustaining Engineer to lead second‑shift manufacturing support and act as the technical lead for assigned production lines. You will diagnose issues, implement corrective actions, and collaborate with Quality, Maintenance, and Supply Chain to meet production goals.

The role emphasizes hands‑on floor support, process ownership, CAPA participation, and mentoring junior engineers in a regulated contract manufacturing environment.

Qualifications

• Bachelor’s degree in a STEM engineering discipline.
• Minimum of 5 years of experience in medical device manufacturing or another regulated industry.
• Strong sustaining engineering, manufacturing support, and process troubleshooting experience in a high‑volume manufacturing environment.
• Demonstrated ability to perform root cause analysis and implement corrective actions.
• Working knowledge of ISO 13485 and GMP requirements.
• Experience with manufacturing process documentation and engineering change management.
• CAD experience (SolidWorks or comparable).
• Experience with MES and ERP systems.
• Strong verbal and written communication skills.
• Hands-on, detail-oriented approach to problem solving.

Responsibilities

• Provide daily hands-on engineering support for manufacturing operations, with primary responsibility for second‑shift production activities.
• Serve as the primary engineering point of contact for assigned production lines; troubleshoot manufacturing and product issues, perform root cause analysis, and implement corrective and preventive actions.
• Partner with Production, Quality, Maintenance, and Supply Chain teams to rapidly escalate and resolve issues, minimize downtime, and drive operational excellence through quality standards, single‑piece flow, waste reduction, and continuous improvement.
• Own and maintain manufacturing processes, work instructions, process documentation, and standard operating procedures for assigned product lines.
• Track and analyze manufacturing performance metrics, including yield, scrap, and process efficiency, and support reporting to management and customers.
• Identify and implement process improvements that increase yield and overall efficiency.
• Prioritize and execute engineering tasks that address urgent production needs and align with business and customer requirements.
• Support quality systems through CAPA investigations, nonconforming material reviews, and customer complaint resolution.
• Ensure 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.

Skills

Sustaining engineering

Manufacturing support

Root cause analysis

Cross-functional

Process troubleshooting

Quality systems

SolidWorks

MES ERP

Technical communication

Education

Bachelor's degree in STEM

Tools

SolidWorks

Job description

POSITION SUMMARY

MANIFEST Technology is seeking a Senior Sustaining Engineer to provide hands‑on engineering support for the manufacture of medical device components, with primary responsibility for second‑shift production operations. Working primarily on the manufacturing floor, this role serves as the technical lead for assigned production lines—maintaining process stability, resolving manufacturing issues, implementing corrective actions, and driving continuous improvement. The Senior Sustaining Engineer partners cross‑functionally with Production, Quality, Maintenance, and Supply Chain teams to meet production and quality objectives within a contract manufacturing environment.

Position Type: Full‑time / Direct Hire

Shift: Second shift; Monday–Thursday, 2:00 p.m.–12:00 a.m.

Work Environment: Primarily manufacturing‑floor support in a regulated contract manufacturing environment

Salary Range: $100,000–$135,000, based on skills and experience

PRIMARY RESPONSIBILITIES

• Provide daily hands‑on engineering support for manufacturing operations, with primary responsibility for second‑shift production activities.
• Serve as the primary engineering point of contact for assigned production lines; troubleshoot manufacturing and product issues, perform root cause analysis, and implement corrective and preventive actions.
• Partner with Production, Quality, Maintenance, and Supply Chain teams to rapidly escalate and resolve issues, minimize downtime, and drive operational excellence through quality standards, single‑piece flow, waste reduction, and continuous improvement.
• Own and maintain manufacturing processes, work instructions, process documentation, and standard operating procedures for assigned product lines.
• Track and analyze manufacturing performance metrics, including yield, scrap, and process efficiency, and support reporting to management and customers.
• Identify and implement process improvements that increase yield and overall efficiency.
• Prioritize and execute engineering tasks that address urgent production needs and align with business and customer requirements.
• Support quality systems through CAPA investigations, nonconforming material reviews, and customer complaint resolution.
• Ensure 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.

REQUIRED QUALIFICATIONS

• Bachelor’s degree in a STEM engineering discipline.
• Minimum of 5 years of experience in medical device manufacturing or another regulated industry.
• Strong sustaining engineering, manufacturing support, and process troubleshooting experience, including 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, such as SolidWorks or a comparable platform.
• Experience with MES and ERP systems.
• Strong verbal and written communication skills.
• Strong problem‑solving skills with a hands‑on, detail‑oriented approach.

PREFERRED QUALIFICATIONS

• Experience with Lean manufacturing principles and continuous improvement methodologies.
• Experience with single‑piece flow manufacturing.