Manufacturing Systems Engineer

About the Role

The Manufacturing Systems Engineer develops, implements, validates, and continuously improves manufacturing systems and processes within an ISO-regulated contract manufacturing environment. This role ensures manufacturing systems (e.g., MES, ERP, PLM) meet customer requirements, support operational efficiency, and enable high-quality, compliant production.

Responsibilities

• Develop manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors; soliciting observations from operators to improve processes and efficiency.
• Improve manufacturing efficiency by applying LEAN, 6S, and Six Sigma methods, analyzing and planning staffing, workflow, space requirements, and equipment layout.
• Assure product and process quality by designing testing methods; testing finished product and process capabilities; establishing standards; confirming manufacturing processes.
• Apply lean manufacturing, DFX, fixture design, part design, and design for manufacturing and assembly (DFMA) practices to implement continuous product improvements.
• Engage Manufacturing Engineering and Production to develop, design, and deploy assembly fixtures and tooling during the pilot launch phase.
• Configure, implement, and maintain MES processes by reviewing product documentation, traceability requirements, and manufacturing methods.
• Support new product introduction (NPI) activities by implementing and validating manufacturing systems.
• Collaborate with cross-functional teams to define and document new system and integration specifications.
• Perform and document testing of software functionality to support new features or software version upgrades.
• Execute system validation activities in accordance with ISO standards and applicable regulatory requirements.
• Develop standard reports to communicate manufacturing and quality metrics organizationally.
• Troubleshoot system issues impacting production, provide hands-on technical support, and implement sustainable corrective actions.
• Develop and maintain documented processes for manufacturing system usage to ensure consistent application of engineering best practices across facilities.
• Train manufacturing teams on system usage, updates, and best practices.
• Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.
• Support Program/Project Managers by providing technical assistance.
• Direct activities and provide guidance and oversight to manufacturing technicians.

Requirements

• Bachelor of Science in Engineering.
• 3+ years’ experience working in an ISO-regulated capital equipment product manufacturing environment.
• Strong knowledge of PLM, ERP, and MES systems; experience with Epicor Kinetic, Aegis FactoryLogix, and SW EPDM software is a plus.
• Working experience with CAD (SolidWorks preferred), MS Office, MS Project, PLM, ERP, and MES systems.
• Good technical aptitude and understanding of electromechanical assemblies.

Working Environment

Generally works in an office environment but may occasionally perform job duties outside of the typical office setting. Occasional travel is required.

Physical Requirements

• Interaction with people and technology while either standing or sitting.
• Must be able to communicate face-to-face, on the phone, and in writing.
• Able to lift up to 50 lbs.