Description:
Process Engineer – Tubing Extrusion is responsible for Execution and implementation of projects of great impact for the organization, related to cost reduction and improvements in the company's productivity. Analysis and solution of critical problems for the operation assigned by the plant. Provides technical support on complex problems to extrusion process and production area technicians. Responsible for the development and analysis of products, materials, processes, or equipment. Compiles, analyzes and reports operational, test, and research data to establish performance standards for newly designed or modified products, processes, or materials.
- Supports Engineers, technicians and operators during project development work.
- Ability to run process and develop procedures as a hands-on operator.
- Lead product development – construct, test, document, and evaluate prototype products for intended release to production.
- Lead process development – DOEs, tooling qualification, process and product validations.
- Perform as a project leader – implement & maintain Development Transfer Control Files for each assigned project, including but not limited to planning & following timelines, documenting processes, and conducting & recording meetings & design reviews.
- Train production on new processes and product assembly.
- Develop specifications / requirements for design of new tooling, fixtures and equipment.
- Research vendors and procure materials needed to complete projects.
- Work from detailed drawings, schematics, and/or verbal and written instructions.
- Prepare and compile new operational and product quality procedures & specifications.
- Communicate with customer in relation to their project: progress, concerns, and product performance requirements.
- Provides technical expertise for the development and investigation of projects and troubleshoots technical problems providing innovative solutions.
- Collaborates with Quality, Supplier Development Manufacturing Operations, and Marketing departments.
- Performs as the principal technical contact assuming the responsibility for the progression of concepts and technologies to provide expert knowledge for the full life-cycle support of project commercialization.
- Ensures alignment across sites to harmonize operations and site-to-site transfer of knowledge, process, Technology and good practices as applicable.
Job Qualifications
- Bachelor’s degree in an engineering or scientific discipline.
- 10+ years of proven experience or an advanced degree and 8+ years of proven experience.
- Professional working experience with medical device design and manufacturing technologies and/or products.
- Expert level experience with integrated extrusion systems, 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.
- In-depth understanding of materials associated with medical devices such as polymers (PVC, nylons, polyethylene, polycarbonate, polypropylene. Knowledge of PEEK, Pebax, PTFE, FEP, silicone is also useful).
- Expert knowledge 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.
- Project management associated with new process/product/technology development and the successful transfer into manufacturing.
- Six Sigma Green belt or equivalent certification beneficial but not required.
- 10% travel.
Competencies/Skills
- Self-motivation and hands-on skills to simplify complex processes.
- Professional experience in exploration of new technologic prospects.
- 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.
- Exceptional problem-solving, organizational, analytical, and critical thinking skills including high discretion/judgment in decision-making.
