Intern – Design Assurance Engineer
Core
Provide design qualification and engineering support throughout product development and manufacturing lifecycle, serving as the focal point for safety agency and regulatory compliance.
Role type
Intern Design Assurance Engineer
Builds
Electro-mechanical medical device prototypes
Domain
Medical devices / Regulatory compliance
Required skills
ISO 13485, FDA QSR, REACH, RoHS, IEC 60601, Risk Management Plan, Design Failure Modes and Effects Analyses, Fault Tree Analyses, Design Verification test activities
Preferred skills
Medical device safety standards (IEC 60601-1, IEC 61010-1), regulatory requirements understanding
Technologies
Lab equipment, debug techniques
Responsibilities
Ensure project activities comply with quality systems and directives; Direct prototype development and documentation; Participate in quality system development; Demonstrate proficiency with lab equipment and debug techniques; Determine specifications for regulatory compliance; Lead Risk Management Plan and analysis development; Participate in Design Verification test activities
Seniority
Intern