MDR - Prin R-D Engineer

Job Title: Prin R-D Engineer
Job ID: 28172
Location: Irvine California 92617
Duration:06 months
Pay Rate: $60.00 - $65.00/hr on W2
 

Top 3 Must-Haves

1. Catheter design & manufacturing experience
2. Design Controls, CAPA, design sustaining & remediation
3. Neurovascular or Cardiovascular medical-device experience

Required Qualifications

• Bachelor’s degree in Engineering, Polymer Science, Science, or related technical field.
• 7–10+ years engineering experience; 10+ preferred.
• 6+ years medical-device experience.
• Strongcatheter development/design and manufacturing experience.
• Strong knowledge ofDesign Controls, CAPA, design remediation, sustaining engineering, and product development.
• Experience withNeurovascular or Cardiovascular devices; Neurovascular strongly preferred.
• Knowledge of clinical/regulatory pathways, medical-device development, IP, and design processes.
• Strong technical leadership, problem-solving, project prioritization, communication, and mentoring skills.

Key Responsibilities

• Design/redesignmedium-to-high complexity neurovascular catheters and subsystems.
• SupportNPD and sustaining engineering programs.
• Develop prototypes, models, experiments, and product evaluations.
• Design and execute testing to verify product performance and customer requirements.
• PrepareDesign Control documentation, engineering reports, presentations, and technical documentation.
• Lead/supportdesign changes, remediation, CAPA, and customer-feedback-driven improvements.
• Participate in pre-clinical/in-vivo activities, hospital observations, and customer interactions as required.
• Collaborate with cross-functional R&D, Quality, Regulatory, Clinical, and manufacturing teams.
• Provide technical leadership, mentoring, and guidance to junior engineers.