Design Assurance Engineer

*IMMEDIATE MEDICAL DEVICE DESIGN ASSURANCE ENGINEER OPPORTUNITY*

DUTIES

• Represents Quality Assurance during the Design Control and Design Review process through review and approval of the applicable Design Input, Design Output, Design Verification, Validation, and Design Transfer.


• Responsible for Design Control, Device Master & Device History Records, Standard Operating Procedures review, Drawings/Specifications review, Change Orders, Quality Systems Manual and company-wide training.


• Responsible for authoring, reviewing and approving test protocols and reports for design DVV activities


• Active participant and leadership in Design and Phase Review meetings per design control internal procedure.


• Participates in risk management activities including the development and authorization of product and process risk analyses, failure mode and effect analyses (FMEA's), and risk assessments


• Inspection techniques, understanding technical documentation including mechanical drawings.


• Excellent written and oral communication

QUALIFICATIONS

• 5 + years experience in medical device industry


• Degree in Engineering


• Experience with PRODUCT design verification/validation

About Aerotek:

Your success starts with the right career opportunity. Aerotek uses a people-focused approach to connect job seekers to incredible opportunities with leading organizations. Established in 1983, we've grown to become a consistent Best of Staffing® winner for talent satisfaction because of our dedication to exceptional service. Serving over 300,000 contract workers every year, we specialize in placing workers with engineering, scientific, professional and industrial skill sets. Aerotek is proud to offer competitive benefits, including contributory medical, dental and vision insurance, weekly pay, discounts on consumer goods and services and more.