Manufacturing/Sustaining Engineer
Listed on 2026-07-23
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Manufacturing / Production
Lean Manufacturing / Six Sigma, Automation & Mechatronics Engineer, Quality Engineering, Maintenance Technician / Mechanic
We are seeking a hands‑on Manufacturing / Sustaining Engineer to support highly automated medical device manufacturing operations. This role is focused on improving equipment reliability, increasing Overall Equipment Effectiveness (OEE), reducing recurring mechanical downtime, and sustaining production across a complex automated assembly environment.
This engineer will spend significant time on the manufacturing floor partnering with Production, Maintenance, Quality, and Engineering to troubleshoot equipment issues, investigate recurring failures, implement permanent corrective actions, and improve long‑term machine performance. Success in this role requires strong mechanical aptitude, excellent root cause analysis skills, and the ability to drive sustainable improvements within an established high‑speed automated manufacturing operation.
Key Responsibilities- Support daily production by providing hands‑on engineering support for highly automated manufacturing equipment and assembly systems.
- Troubleshoot recurring mechanical, pneumatic, electrical, and automation‑related equipment issues to minimize downtime and restore production quickly.
- Perform Root Cause Analysis (RCA) using structured problem‑solving methodologies such as 5 Whys, Fishbone, DMAIC, and failure analysis to eliminate recurring equipment failures.
- Improve Overall Equipment Effectiveness (OEE) by identifying equipment losses, implementing corrective actions, and driving long‑term reliability improvements.
- Analyze production performance, downtime, scrap, cycle time, and machine efficiency data to identify trends and prioritize improvement opportunities.
- Partner with Production, Maintenance, and Quality teams to sustain manufacturing performance and achieve production output targets.
- Investigate chronic machine performance issues and develop permanent corrective actions to improve equipment reliability.
- Support preventive and predictive maintenance initiatives by identifying equipment improvements that reduce mechanical failures and increase uptime.
- Update manufacturing procedures, work instructions, troubleshooting guides, and preventive maintenance documentation to improve equipment consistency and technician effectiveness.
- Provide technical guidance and training to manufacturing technicians on equipment operation, troubleshooting techniques, and process improvements.
- Collaborate with OEM equipment manufacturers and external vendors to resolve complex equipment issues and support equipment upgrades.
- Support engineering changes, equipment modifications, validation activities, and continuous improvement initiatives.
- Participate in capital equipment projects including installation, startup, qualification, commissioning, and production release.
- Ensure all engineering activities comply with FDA, GMP, ISO, and company quality system requirements.
- Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related engineering discipline.
- Minimum 3–7 years of manufacturing engineering experience supporting automated production equipment.
- Strong mechanical troubleshooting skills within automated manufacturing environments.
- Demonstrated experience improving Overall Equipment Effectiveness (OEE) and equipment reliability.
- Experience performing Root Cause Analysis (RCA) and implementing permanent corrective actions.
- Experience supporting daily production within high‑volume manufacturing environments.
- Strong understanding of preventive maintenance, Total Productive Maintenance (TPM), and equipment reliability principles.
- Experience analyzing manufacturing performance metrics including downtime, cycle time, throughput, scrap, and OEE.
- Excellent problem‑solving, communication, and cross‑functional collaboration skills.
- Ability to work effectively in a fast‑paced production environment.
- Medical Device manufacturing experience.
- High‑speed automated assembly equipment.
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