Flexan is a global strategic contract manufacturer of custom high-quality silicone and thermoplastic components, sub-assemblies and devices designed to meet the critical requirements of Class I, Class II and Class III medical devices, as well as custom compounding and molding for precision parts.

The Project Engineer's primary responsibility is 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. The Project Engineer is also responsible for developing tooling and coordinating with tooling vendors for mold/fixture builds.

DUTIES AND RESPONSIBILITIES

• Complete projects, report status, and document lessons learns in and efficient manner. Utilize project management tools in establishing timelines, building action item 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 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.

• Closely work with tooling vendors for mold builds that meet cost, quality and delivery expectations.

• Execute validation and qualification (IQ/OQ/PQ) protocols for new product, 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 on 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.

• Demonstrates all of the Flexan’ s corporate values:

  • We have an engaged culture

  • We embrace the rigor to be safety and quality driven in all we do
  • We embrace the choice to work here
  • We operate with transparency, ethics, and integrity
  • We consistently meet our expectations

EDUCATION AND EXPERIENCE

• Bachelor of Science from a four year college or university in an engineering or science related field

• 5+ years experience in the medical field with catheter assembly experience

• Experience in Electronics and process transfers.

• 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)

It is the policy of Flexan, LLC to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Flexan will provide reasonable accommodations for qualified individuals with disabilities.

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