The Process Engineer is primarily responsible to interface with sales and customers to define customer requirements and specifications and utilize management tools in establishing timelines, building action item lists, assigning responsibility, completion dates and achieving milestones. Additionally, provide technical assistance and engineering support to the manufacturing floor. This individual will assist in developing processes and work with Process Engineers in developing new processes.

MINIMUM QUALIFICATIONS:

• Bachelor of science from a four-year college or university in a project engineering related field.
• 5 years of experience in the Medical Device Industry preferred.
• Must have advanced skills in Microsoft Word, Excel, PowerPoint, and Minitab (or other statistical analysis software). SOLIDWORKS or CAD modeling software is a plus, windows-based software (Visual ERP)

• Complete projects, report status, and document lessons in an efficient manner. Utilize project management tools in establishing timelines, building action items lists, assigning responsibility, completion dates and achieving milestones.
• Lead flawless launch activities and solicit active participation in feasibility meetings, FMEA, DFM, part print review, tool design review and kaizen events using cross-functional teams.
• Provide timely support to quoting team in determining the most efficient manufacturing methods and tool design concepts that will lead to competitively quoted products and prompt RFQ response.
• Interface with the sales team and customers to clearly define customer requirements and specifications.
• Work closely with tooling vendors that meet cost, quality and delivery expectations.
• Execute validation and qualification (IQ/OQ/PQ) protocols for new products, equipment, tooling, and processes. Follow SOP on re-validation of existing equipment, tooling and processes.
• Develops new processes, sampling activities and as well as tooling and manufacturing concepts that will meet customer expectations regarding cost, quality and delivery.
• Provide technical assistance and engineering support to the manufacturing floor in ensuring production of quality products. Work with other support departments to maintain on-time delivery goals.
• Lead process improvement and waste elimination efforts through application of lean principles and actively participate in continuous improvement events.
• Works with Quality Control team to generate, update and implement all project-related documentation including control plans, work instructions, manufacturing procedures, sample request, process guides and troubleshooting guides.
• Other duties as assigned by the Engineering Manager