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Catheter R&D Engineer
Accepting applicationsLumicity · Los Angeles Metropolitan Area
Full-Time Mid_senior aiasicaterf
Posted
4 May
Category
Test
Experience
Mid_senior
Country
N/A
Key Responsibilities
Design and develop catheter-based devices and components, including shafts, hubs, balloons, and delivery systems.
Create and iterate prototypes using a variety of materials and fabrication techniques (e.g., extrusion, reflow, bonding, laser cutting).
Conduct engineering testing (bench, simulated use, and environmental) and analyze data to inform design decisions.
Develop and execute design verification and validation (DV&V) protocols and reports.
Collaborate cross-functionally with Quality, Regulatory, Manufacturing, and Clinical teams.
Support risk management activities, including hazard analysis and mitigation strategies.
Generate and maintain design history file (DHF) documentation in compliance with regulatory requirements.
Assist with process development and technology transfer to manufacturing.
Troubleshoot product and process issues, perform root cause analysis, and implement corrective actions.
Contribute to continuous improvement initiatives and engineering best practices.
Education & Experience
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or related field.
Minimum 2+ years of experience in medical device R&D, preferably with catheter-based or minimally invasive devices
Technical Skills
Hands-on experience with catheter design, materials, and manufacturing processes (e.g., polymers, braiding, coiling).
Familiarity with test methods for catheter performance (e.g., tensile, burst, torque, trackability).
Ability to interpret engineering drawings and apply GD&T principles.
Experience with CAD software (e.g., SolidWorks or equivalent).
Strong analytical and problem-solving skills with attention to detail
Regulatory & Quality Knowledge
Basic understanding of FDA regulations (21 CFR Part 820) and ISO 13485.
Familiarity with design controls, risk management (ISO 14971), and documentation practices.
Soft Skills
Strong communication and teamwork skills.
Ability to manage multiple projects and priorities.
Proactive mindset with a willingness to learn and adapt.
Show more Show less
Design and develop catheter-based devices and components, including shafts, hubs, balloons, and delivery systems.
Create and iterate prototypes using a variety of materials and fabrication techniques (e.g., extrusion, reflow, bonding, laser cutting).
Conduct engineering testing (bench, simulated use, and environmental) and analyze data to inform design decisions.
Develop and execute design verification and validation (DV&V) protocols and reports.
Collaborate cross-functionally with Quality, Regulatory, Manufacturing, and Clinical teams.
Support risk management activities, including hazard analysis and mitigation strategies.
Generate and maintain design history file (DHF) documentation in compliance with regulatory requirements.
Assist with process development and technology transfer to manufacturing.
Troubleshoot product and process issues, perform root cause analysis, and implement corrective actions.
Contribute to continuous improvement initiatives and engineering best practices.
Education & Experience
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or related field.
Minimum 2+ years of experience in medical device R&D, preferably with catheter-based or minimally invasive devices
Technical Skills
Hands-on experience with catheter design, materials, and manufacturing processes (e.g., polymers, braiding, coiling).
Familiarity with test methods for catheter performance (e.g., tensile, burst, torque, trackability).
Ability to interpret engineering drawings and apply GD&T principles.
Experience with CAD software (e.g., SolidWorks or equivalent).
Strong analytical and problem-solving skills with attention to detail
Regulatory & Quality Knowledge
Basic understanding of FDA regulations (21 CFR Part 820) and ISO 13485.
Familiarity with design controls, risk management (ISO 14971), and documentation practices.
Soft Skills
Strong communication and teamwork skills.
Ability to manage multiple projects and priorities.
Proactive mindset with a willingness to learn and adapt.
Show more Show less