HW V&V Consultant (Remediation/IEC/testing/audit) Job in Burlington, Massachusetts US
HW VV Consultant (Remediation/IEC/testing/audit)
We currently have a 4-6month contract in Burlington, MA for a remediation project. We are looking for multiple people with both Project Lead experience and principle engineers. Please email your resume to Todd. Click Here to Email Your Resume for review Scope of Work - Work with a team of professionals on HW system retrospective validation of Older Design History Files. - Working with internal RD and Quality Regulatory personnel review older Design History Files and document these file into today's current business processes, make recommendations, for change/improvement, developed test scenarios, set up audit and workflow processes. - Developed traceability Matrix for testing, User and Functional Requirements specifications, and test summary close out reports Requirements: - BSME with a strong background in design (solidworks), packaging, product safety testing and documentation - 5-10 years as a Mechanical design engineer with product and VV testing either as a Lead or Principle Engineer - Strong Product and Process auditing background - Understanding of the IEC standards, UL, CSA, TUV, (exposure to FDA standards/preferred) - Strong background in fiber optics, PCB, fixtures, cables, and harnesses Experience providing objective evidence that the released for distribution products are being manufactured to their DMRs and with controlled process To provide ample evidence that the products, as manufactured safe and effective for their intended use