The Validations Engineer position is primarily responsible for testing the systems used to develop or manufacture our extruded products to ensure the highest quality products are created. This position could also provide general manufacturing support. Troubleshooting problems with production or with customer requirements. These responsibilities require a high competency in communication, project planning and team building. + Support new product development activities as directed in the development of Master Validation Plans, PFMEA’s, Control Plans, gauging methodology comparisons, First Article Reports, etc. + Conduct and manage product, process, and equipment validations from concept to completion. + Write testing protocols and reports. Develop project plans including equipment, personnel, and budgets. + Communicate with stakeholders in the process, including customers and other personnel or departments who will be affected by testing. + Independently apply analytical skills and tools (like statistical process control, design of experiments, etc.), complex scientific technical principles, and detailed knowledge in solving engineering problems + Perform Measurement System Analysis (MSA). + Support new product quoting and development and ongoing production needs with product specification review of the customer specified tubing components. + Develop and/or improve and implement procedures and work instructions in current quality system. + Ability to fulfill Spectrum Plastics Group’s Quality Statement goals and complete documentation within quality system requirements. + Perform product measurement and testing. Ability to detect quality defects. + Complete other duties as assigned. Qualifications Candidate Requirements: + Bachelor’s degree in engineering (or related technical field). + Prefer 3 years’ experience in extrusion. + Prefer 3 years’ experience in the Medical Device field. + Knowledge of ISO 9001, ISO13485 and GMP standards. + Ability to read technical documents and drawings. + Familiarity with plastic materials. + Strong statistical skill set. + Strong Technical writing. + Proficiency in Excel, Minitab or equivalent. + Bilingual: Spanish/English is a plus. + Professional working experience with medical device design and manufacturing technologies and/or products. + Experience with Test Method development, protocol generation, execution, and reporting. + Experience mentoring junior members of the technical staff. + GMP and ISO 9000 training. + Experience with tooling design with advanced SolidWorks CAD knowledge. Preferred but not required. + Understanding of materials associated with medical devices such as polymers (PVC, nylons, polyethylene, polycarbonate, polypropylene. + Understanding of polymer extrusion processes and equipment including medical polymeric materials, diameters ranging from 0.030” to 1.0” diameter parts, single and multi-lumen profiles, para-tubing, co-extrusion applications, bump tubing, striping, etc. + Understand customer requirements and applications. + Six Sigma Greenbelt or equivalent certification beneficial but not required. + 25% travel. Competencies/Skills • Self-motivation and hands-on skills to simplify complex processes. • Capability to establish change and encourage the inter-organizational exchange of skills. • Excellent communication and interpersonal skills combined with the ability to interact with and influence all levels of the business and clients. • Good problem-solving, organizational, analytical, and critical thinking skills including high discretion/judgment in decision-making.