Manufacturing Engineer
JOB DESCRIPTION SUMMARY: Provide engineering support for complex manufacturing equipment for the high-volume manufacturing of medical devices. Provide technical, engineering, validation and documentation support. This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision.
The Manufacturing Engineer will become part of a highly engaged, driven and successful team in support client's unique portfolio of medical device, drug and cosmetic products produced at our world-class manufacturing facility. Who we want Collaborative partners.
People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement. Analytical problem solvers.
What you will do As Manufacturing Engineer, you will provide technical and engineering support for manufacturing equipment that supports Needle Punch and Label Printing Operations.
Responsibilities include: Support engineering and project management in FAT, installation, and commissioning of new equipment.
Develop equipment and utility layouts using AutoCAD (or similar) to support department relocation and installation of new equipment. Support installation of new equipment, including layout planning, utility coordination, and integration into existing processes. Interface with OEMs, contractors, and internal engineering teams to resolve design gaps and coordinate field changes on the fly.
Develop and maintain process FMEAs and control plans for new and existing equipment. Complete process validations including VP, URS, IQ, OQ, PQ and associated documentation.
Develop appropriate supporting documentation, SOPs and work instructions compliant with Good Manufacturing Practices (GMP). Collaborate with product and manufacturing engineering, equipment vendors, maintenance technicians and operations leadership to troubleshoot process and equipment issues.
Support line performance monitoring and lead practical problem solving (PPS) projects to remediate systemic issues
What you need Minimum qualifications: B.S. in Engineering or related field required. Two years experience in manufacturing engineering, mechanical engineering, or related field.
Demonstrated interest and experience supporting manufacturing operations, troubleshooting automation equipment, and implementing process improvements.
Hands-on technical contributor comfortable working on the floor, assisting with equipment placement, alignment, and startup activities.
Preferred Qualifications
Medical Device industry experience (ie. internship). Demonstrated experience writing and executing validations (IQ, OQ, PV, etc.).
Demonstrated hands on experience working in a manufacturing environment. Demonstrates excellent interpersonal communication, collaborative teamwork, and problem solving. Familiarity with reading electrical schematics.
