Design Assurance Engineer
Posting ID: JP-001972324
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. Knowledge of quality requirements for medical device manufacturing and requirements for inspection and testing. Understanding of risk management principles for medical devices per ISO 14971. Understanding of quality management systems for medical devices per ISO 13485 Influences the product development process through core team lead and has responsibility for effective transfer validation to operations to assure product quality and regulatory compliance Integral part of project team to launch new products
FMEA, new product development, risk analysis, design control, biocompatibility, research & development
Top Skills Details:
Product design verification & validation, design assurance, risk analysis, new product development, FMEA's
Additional Skills & Qualifications:
Degree in Engineering - Mechanical or Biomedical preferred. Minimum 5 years experience
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Recruiter: Gonzalez, Abel