Job SummaryThe Manufacturing Systems Engineer is responsible for developing, implementing, validating, and continuously improving manufacturing systems and processes within an ISO-regulated contract manufacturing environment. This role ensures that manufacturing systems (e.g., MES, ERP, PLM) are implemented to meet customer requirements, support operational efficiency, and enable high-quality, compliant production.
Duties and Responsibilities- Develops 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.
- Improves manufacturing efficiency by applying LEAN, 6S and Six Sigma methods, analyzing and planning staffing, workflow, space requirements, and equipment layout.
- Assures product and process quality by designing testing methods; testing finished product and process capabilities; establishing standards; confirming manufacturing processes.
- Proficient level of understanding or background in lean manufacturing, DFX, fixture design, part design, design for manufacturing and assembly practices.
- Implements continuous product improvements aimed at improving reliability, design for manufacturability and assembly (DFMA), as dictated by customer or business needs and requests.
- 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 (SPL) 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.
- Maintains 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.
Qualifications- Bachelor of Science in Engineering.
- 3+ years' experience working in an ISO regulated capital equipment product manufacturing environment.
- Strong knowledge of PLM, ERP, MES; Epicor Kinetic, Aegis FactoryLogix, and SW EPDM software experience 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 be required to perform job duties outside of the typical office setting. Occasional travel 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.
Note: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and/or skills required of all personnel so classified.
Compensation: $75,000.00 - $90,000.00 per year
