Bedford, Massachusetts, United States · On-site
$45/hr–$55/hr
Description 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 manufa…
Skills: Design Controls, Risk Management, Verification and Validation, Root Cause Analysis, CAPA
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Ensure new catheter and console products meet regulatory and quality requirements throughout design, development, and manufacturing transfer. Lead complaint investigations, risk analysis, and CAPA efforts while supporting on-site manufacturing quality inspections.
Requires a bachelor's degree in science or engineering and at least 5 years of experience in sterile disposable or electro-mechanical medical device development. Must have deep knowledge of medical device design controls and international regulations such as ISO 13485 and FDA 21 CFR Part 820.
Description
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.
Essential Responsibilities
Requirements
Experience & Qualifications
Required:
Preferred:
Advancing cerebrovascular care through groundbreaking neuro intravascular imaging and AI technologies.
Advancing cerebrovascular care through groundbreaking neuro intravascular imaging and AI technologies.
Offices: 4 Crosby Dr, Suite 4.2, Bedford, Massachusetts 01730, US
Advancing cerebrovascular care through groundbreaking neuro intravascular imaging and AI technologies.
Advancing cerebrovascular care through groundbreaking neuro intravascular imaging and AI technologies.
Offices: 4 Crosby Dr, Suite 4.2, Bedford, Massachusetts 01730, US
