Manufacturing Engineer - Medical Device Manufacturing

Job Overview

This role supports the sustaining engineering team focused on legacy production equipment. It is a highly hands-on position with a strong emphasis on keeping machines running, troubleshooting issues impacting output, and supporting day-to-day manufacturing operations.

The role is ~75% reactive troubleshooting and ~25% process improvement. It is not project-heavy or design-focused — the priority is identifying problems quickly and working cross-functionally to resolve them.

Day-to-day responsibilities include:

• Troubleshooting mechanical, electrical, and PLC-related issues on semi-automated equipment

• Breakdown: ~50% mechanical, 25% electrical, 25% PLC (no programming required – troubleshooting only)

• Supporting 3–4 key automated machines, including:

– Embedding machines (injecting detergent into sponge material)

– Packaging/flow wrap systems (cutting, wrapping, labeling)

– Pouching/forming equipment

– Multivac thermal forming and similar systems

• Partnering with operators and technicians to understand daily output gaps

• Performing root cause analysis on downtime and performance issues

• Supporting process improvements and process change analysis (~monthly cadence)

• Assisting with validation activities (IQ/OQ/PQ) during new equipment installs (a few times per year)

• Ensuring compliance within a regulated (FDA/ISO) manufacturing environment

Required Qualifications

• 3–5+ years of experience in a manufacturing or engineering environment

– Open to ~2 years if candidate is very hands-on and a quick learner

• Strong mechanical troubleshooting experience (priority)

• Working knowledge of electrical systems and PLC troubleshooting

• Experience supporting production equipment uptime/reliability

• Ability to perform root cause analysis in a fast-paced production setting

• Experience working in a regulated environment (FDA, ISO, etc.)

• Exposure to validation activities (IQ/OQ/PQ) and documentation

• Strong communication skills and ability to work cross-functionally on the floor

Preferred Qualifications

• Medical device manufacturing experience

• Familiarity with CAPA, non-conformance investigations, and quality systems

• Experience driving process improvements (uptime, efficiency, error-proofing)

• Experience supporting automated packaging or forming equipment (Multivac a plus)

• Experience mentoring or supporting technicians/operators

Additional Notes

• Extremely hands-on, reactive role — not project-based engineering

• Focused on sustaining equipment and maintaining production output

• Looking for someone who can come in and quickly troubleshoot and add value

• Manager values strong problem solvers with ownership and willingness to learn