Principal R D Engineer ATR International - 3.8 Irvine, CA Job Details Contract $70 - $100 an hour 19 hours ago Qualifications Product design project leadership Polymers experience in materials engineering Anatomy knowledge Product development project management Mechanical assembly Defect resolution root cause analysis Verification (System development task) Performance testing in mechanical engineering Medical device testing Materials engineering experience within manufacturing Regulatory compliance Quality control preventive actions Corrective and preventive actions (CAPA) Collaboration with product development teams Managing engineering teams Quality risk management Design engineering Leading team collaboration initiatives Design controls Biomedical regulatory compliance Biomedical manufacturing processes Materials science Mechanical product validation projects Product quality failure Mechanical knowledge Cross-functional communication Failure analysis
Full Job Description Employment Type:
6-month contract
Location:
Irvine, CA 92617 Pay range: $70-100 / hour
Position Overview:
As a Principal R D Development Engineer, you will lead the design and development of life-saving medical devices, with a primary focus on neurovascular catheters. In this role, you will work under general direction in a project lead capacity, acting as a functional core team member and leading extended project teams. You will drive product innovation from early concept through design control, testing, optimization, and remediation.
Key Responsibilities:
Design & Innovation:
Design and iterate medium-to-high complexity neurovascular medical devices, catheters, and subsystems. Contribute inventions, novel designs, and advanced technical solutions to the medical and scientific community.
Testing & Optimization:
Design and execute complex experimental protocols, numerical verifications, and evaluations to optimize device performance. Collaborate with cross-functional teams to ensure designs meet internal and external customer requirements.
Prototyping & Clinical Insights:
Create and evaluate prototypes for concept approval. Participate in pre-clinical in vivo labs, observe hospital procedures, and gather feedback through direct customer interactions to drive design improvements.
Sustaining & Design Control:
Support New Product Development (NPD) and Sustaining Engineering programs. Manage design remediation, CAPA (Corrective and Preventive Action) systems, and failure analysis/root cause investigations.
Documentation & Compliance:
Prepare engineering reports, risk documentation, analytical presentations, and design control documentation in full accordance with internal SOPs and regulatory standards.
Technical Leadership & Mentorship:
Apply advanced techniques to resolve complex engineering challenges. Provide technical guidance, training, and mentorship to junior engineering staff.
Project Execution:
Maintain accountability for project deliverables, timelines, and program milestones while managing multiple high-priority tasks.
Required Qualifications:
Education:
Bachelor's degree in Polymer Science, Biomedical Engineering, Mechanical Engineering, or a related technical discipline.
Experience:
10+ years of total engineering experience (or 7-10+ years with strong specialization). 6+ years of direct experience in the medical device industry.
Core Technical Expertise:
Proven experience in catheter design, development, assembly, and manufacturing processes. Deep understanding of polymer material science and its applications in catheter development. Hands-on experience with catheter testing, failure analysis, and root cause investigation.
Quality & Regulatory:
Strong understanding of design control processes, CAPA management, design remediation, and clinical/regulatory pathways.
Industry & Clinical Knowledge:
In-depth understanding of neurovascular (or cardiovascular) anatomy, clinical procedures, and competitor product landscapes.
Leadership & Communication:
Excellent cross-functional communication skills, with a track record of driving decision-making, leading technical initiatives, and collaborating effectively across teams.
Preferred Qualifications:
Hands-on experience designing neurovascular catheters, delivery systems, and guidewire systems. Experience with metal processing techniques (braiding, coiling, laser cutting) and polymer processing techniques (extrusion, reflow, injection molding, blending), including a strong understanding of process-structure-property relationships. Expertise in custom tooling and equipment design for catheter manufacturing. Familiarity with intellectual property (IP) landscape evaluation and strategy.
Top Role Priorities:
Deep, hands-on experience in catheter design and manufacturing processes . Robust background in design controls, CAPA systems, design sustaining, and remediation . Direct background developing neurovascular or cardiovascular interventional devices . #IND3
