Secondary Ops Engineer / Process Engineer

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.

Preferred 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