Job Description
We are partnering with a growing, regulated manufacturing organization seeking a hands-on Manufacturing Engineering to support a fast-paced production environment focused on quality, efficiency, and continuous improvement. This is a high-impact role for someone who enjoys combining technical engineering expertise with leadership in a production setting. The ideal candidate will work closely with Production, R&D, and Quality teams to improve processes, drive automation initiatives, and ensure manufacturing stability and compliance.
Role Overview
The Manufacturing Engineering will lead key engineering activities within the plant, including process development, equipment support, validation, and continuous improvement. This role is both strategic and hands-on, requiring strong shop-floor presence and the ability to solve technical problems in real time.
A strong emphasis will be placed on process validation (IQ/OQ/PQ), automation initiatives, and improving overall equipment reliability and production performance in a regulated manufacturing environment.
Key Responsibilities
- Lead manufacturing engineering and technical operations support
- Drive process development, validation, and ongoing optimization (IQ/OQ/PQ)
- Support and lead automation and manufacturing improvement projects
- Troubleshoot production and equipment issues on the shop floor
- Improve process reliability, efficiency, and throughput
- Lead root cause analysis and corrective actions for production issues
- Partner with R&D, Quality, and Operations on new product introductions (NPI)
- Support lean manufacturing and continuous improvement initiatives
- Oversee engineering documentation including work instructions and process flows
- Contribute to equipment selection, installation, and maintenance strategies
- Ensure compliance with regulated manufacturing standards (FDA / ISO environments)
Ideal Background
- Strong experience in manufacturing or process engineering roles
- Hands-on experience with process validation (IQ/OQ/PQ)
- Background in regulated manufacturing (medical device strongly preferred)
- Experience with automation or equipment improvement projects
- Strong understanding of lean manufacturing and continuous improvement principles
- Comfortable working in a fast-paced, production-driven environment
- Strong problem-solving, leadership, and communication skills
- Engineering degree (Mechanical, Electrical, Biomedical, or related field)