Manufacturing Process Engineer - Extrusion

Manufacturing Process Engineer - Extrusion

Carlsbad - US

What we value:

• Honesty & Integrity: Uphold ethical standards and a strong work ethic.
• Passion & Curiosity: Show enthusiasm for medical device engineering and continuous learning.
• Problem Solving & Learning Ability: Demonstrate problem-solving skills and seek professional growth.

Key responsibilities:

• Perform engineering work related to design, development, procurement, fabrication of extruded components or subassemblies.
• Perform engineering work related to installation of manufacturing equipment, tooling, fixtures and all related documentation including specifications, verification/validation activities, manufacturing procedures.
• Lead development and improvement related to stability and capability of extruded components.
• Work with suppliers/vendors/manufacturer on sourcing materials related to extrusion, shafts, braiding.
• Responsible for achieving metrics including yield, efficiency, and support various areas of manufacturing for the Synaptic Medical business.

What we are looking for:

• Bachelor's Degree in Material Science and Engineering, with a minimum of 3+ years relevant experience in extrusion process/technologies. Advanced degree preferred.
• Relevant experience in medical devices, cardiovascular extruded products highly preferred.
• Experience in a regulated environment; preferably a medical device
• Knowledge of FDA regulations and interpretation of FDA regulations, guidelines and policy statements.
• Experience with extensive polymer and material science.
• Skilled in evaluating performance and user/clinical requirements to provide extruded tubing solutions.
• Proficient in advanced statistical techniques for tubing.
• Expertise in process development for single/multi-lumen, multi-layer, reinforced, PTFE-lined, and multi-durometer sectioned tubing.
• Experienced with various materials including polyurethane, polyolefin, PET, HDPE, PA, PEBAX, and nylon.
• Knowledgeable in balloon forming processes and related equipment, tooling, and system controls.

What we offer:

• Impactful work in the medical device industry.
• Collaborative environment and career development.
• Comprehensive benefits, including medical, dental, vision, 401(k), PTO, and disability support.