Process Engineer

The Process Engineer Tubing Extrusion is responsible for Execution and implementation of projects within the Fluid Management Division related to cost reduction and improvements in the companys 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.

Job Description:

• 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 an active member 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.
• Ensures alignment across sites to harmonize operations and site-to-site transfer of knowledge process Technology and good practices as applicable.

Candidate Requirements:

Bachelors degree in an engineering or scientific discipline.

5 years of proven experience or an advanced degree and 3 years of proven experience.

Professional working experience with medical device design and manufacturing technologies and/or products.

Experience with integrated extrusion systems Test Method development protocol generation execution and reporting.

Experience mentoring other members of the technical staff.

GMP and ISO 9000 training.

Experience with tooling design with advanced Solidworks CAD knowledge.

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).

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.

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.