3+ years experience in the medical device industry
Familiarity with complaint investigations and CAPA processes
Proficient in evaluating nonconforming material
Experience with catheters or sterile disposables
Knowledge of process validation (IQ/OQ/PQ)
Strong understanding of design control and risk analysis
Familiarity with FMEA and sustaining engineering
Responsibilities
Ensure new and existing catheter and console products meet regulatory and quality standards
Collaborate closely with cross-functional teams during product development
Participate in all phases of the product development process
Conduct reliability testing and manage design controls
Oversee input requirements and early design feasibility testing
Execute verification, validation, and manufacturing process development
Manage product risk analysis and delivery
Benefits
Collaborative work environment
Involvement in innovative medical device development
Opportunities for cross-functional teamwork
Engagement in all phases of product lifecycle
Contributions to enhancing patient care through quality assurance
Full Job Description
Responsibilities:
This role will be responsible for ensuring the new catheter and console products and design changes to existing products meet regulatory and quality requirements throughout the design, development, and manufacturing transfer process.
This will be accomplished through close collaboration with cross-functional teams. The Quality Engineer participates in all phases of the product development process.
This includes development, reliability testing, design controls, input requirements, early design feasibility testing and verification and validation, manufacturing process development activities, product risk management requirements, and delivery.
