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.
