MDR - Prin R-D Engineer
Artech LLC
Job Description
Job Description
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
- Catheter design & manufacturing experience
- Design Controls, CAPA, design sustaining & remediation
- Neurovascular or Cardiovascular medical-device experience
- Bachelor’s degree in Engineering, Polymer Science, Science, or related technical field.
- 7–10+ years engineering experience ; 10+ preferred.
- 6+ years medical-device experience .
- Strong catheter development/design and manufacturing experience.
- Strong knowledge of Design Controls, CAPA, design remediation, sustaining engineering, and product development .
- Experience with Neurovascular 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.
- Design/redesign medium-to-high complexity neurovascular catheters and subsystems .
- Support NPD and sustaining engineering programs.
- Develop prototypes, models, experiments, and product evaluations.
- Design and execute testing to verify product performance and customer requirements.
- Prepare Design Control documentation, engineering reports, presentations, and technical documentation .
- Lead/support design 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.
Vacancy posted 11 days ago
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