Secondary Ops Engineer / Process Engineer

Job DescriptionJob Description

Position Summary:

We are seeking a detail-oriented and hands-on Secondary Operations Engineer / Process Engineer to join our medical tubing manufacturing team. This role is responsible for the development, validation, and continuous improvement of secondary operations processes to ensure high-quality, cost-effective production of medical-grade tubing products. The ideal candidate will bring strong technical skills, process engineering experience, and a deep understanding of quality standards within a regulated manufacturing environment.

Key Responsibilities:

• Develop, implement, and optimize secondary operations for medical tubing, including cutting, hole punching, tipping, flaring, bonding, printing, molding and assembly.
• Design and validate fixtures, tools, and equipment to support post-extrusion processes.
• Collaborate with suppliers and equipment vendors for tooling design, maintenance, and upgrades.
• Create, implement and maintain process documentation (work instructions, process flows, validation protocols, etc.).
• Work with cross-functional teams (R&D, Quality, Production) to support new product introductions and process scale-up.
• Collaborate with Sales on evaluating and quoting new products, new product development and customer support. Participate in weekly review meetings to align capabilities with customer specifications.
• Work with quality to conduct root cause analysis and lead corrective/preventive actions (CAPA) for process issues or non-conformances.
• Train and support operators on new or revised secondary processes.
• Follow and maintain a schedule of active projects and give necessary updates.
• Drive continuous improvement and cost reduction initiatives using lean manufacturing and Six Sigma principles.
• Facilitate project scale up activities including transferring manufacturing across multiple locations.

Qualifications:

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or related field.
• 5+ years of experience in medical device manufacturing or plastic tubing industry.
• Hands-on experience with secondary operations processes and automation.
• Familiarity with GMP, ISO 13485, and FDA regulations.
• Strong troubleshooting skills and knowledge of statistical process control.
• Experience with validation (IQ/OQ/PQ) and process documentation.
• Excellent communication, documentation and project management skills.

Skills:

• Experience with laser cutting, RF welding, or thermal bonding.
• Proficient in CAD software (SolidWorks or similar) and Microsoft Office Suite.
• Knowledge of polymer materials commonly used in medical devices (e.g., PVC, Pebax, Polyurethane).
• Lean Six Sigma certification (Green Belt or higher).
• Bilingual in Spanish, a plus
• Prior Secondary Operations experience on molded or manufactured parts

“Proterial Cable America, Inc. is a second chance employer. We believe in giving individuals who have made past mistakes an opportunity to rebuild their lives and contribute positively to society. People with criminal records are encouraged to apply.”