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Manufacturing Engineer III
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Job Title: Manufacturing Engineer III
Location: St. Petersburgh, FL (On site)
Job Type: 12+ month contract
Job Description:
The job function of a Manufacturing Engineer is to provide technical contributions for both commercialized and new products. This position is responsible for the processes, equipment, documentation, and related supplier capability required to manufacture assigned products. The scope of the position includes routine production line support, product improvement projects, and new product introduction activities. The focus of the position is to continually improve product quality, delivery, and cost, both on the factory floor and from the related suppliers.
- Technical Competence: Process and apply a broad knowledge of Mechanical, Electrical, Electro-Mechanical, or Industrial Engineering disciplines. Perform analysis and problem solving for manufacturing non-conformances. Perform lab experiments to collect and summarize data in order to develop new processes or solve problems. Apply the fundamental concepts, practices and procedures required to perform manufacturing engineering disciplines such as 5S, Lean, and Six-Sigma.
- Manufacturing Process Development and Controls: Design the work-flow of manufacturing processes. Write procedures, work instructions and test documentation. Research, design and create specifications to eliminate or reduce top process constraints. Prepare capital expenditure package including ROI to address capacity limiters within the process. Identify opportunities for quality defects to occur in manufacturing processes and suggest mitigations.
- Manufacturing Equipment and Test Development: Conduct production ready design of tools and fixtures using SolidWorks. Write specifications for new equipment. Lead installation of major equipment installations. Identify Critical to Quality specifications to ensure through testing of all changes. Independently test and debug equipment.
- Product and Process/Equipment Documentation: Capable of working independently to create BOM’s, assembly drawings, work instructions. Create a Device Master Record for medical equipment per ISO 13485 guidelines.
- Product Change Management: Create documentation required for product design changes. Initiate and lead the activities required to gain cross-functional approval and implement changes.
- Supplier Capability Development: Work on cross-functional teams to assess and validate supplier process capability for new products, improve existing supplier processes, and participate in experiments to determine root cause analysis of supplier quality issues.
- New Product Development: Represent manufacturing engineering on cross-functional teams to assess supplier capabilities, develop packaging solutions, and create operational and process qualification protocols for new products and processes.
- New Product Realization/Commercialization: Contribute to design transfer activities such as process validations. Participate in post-new product launch issue resolution teams.
- Cost Reduction: Responsible for project managing and administration of multiple cost improvement projects.
- Project Management: Represent manufacturing engineering on cross-functional teams to design and validate new products, improve processes, and perform root cause analysis.
- Minimum 5 years Manufacturing Engineering experience
- BS Mechanical, Electrical, or Industrial Engineering
- Demonstrated analytical and problem solving skills
- Demonstrated initiative and ability to achieve results
- Quality Management Systems exposure
- Strong verbal and written communication skills
- Demonstrated teamwork and collaborating behaviors
- General computer applications such as Excel, Access, Visio, Tableau
- MS Mechanical, Electrical, or Industrial Engineering
- ISO 13485/FDA Regulation Experience
- CAD experience, preferably SolidWorks
- ERP knowledge, preferably SAP
- PLM knowledge, preferably Agile
