Manufacturing Engineer
System One Holdings, LLC
Manufacturing Engineer
Join a leading medical technology manufacturer as a Manufacturing Engineer supporting equipment installations, process improvements, and production optimization within a dynamic manufacturing environment. This hands-on contract opportunity offers the chance to work cross-functionally on automation, validations, and continuous improvement initiatives while making a direct impact on operational performance and product quality.
Responsibilities:
- 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.
Requirements:
- 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.
- 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.
System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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