Test Engineer Jobs

Req Number: 1293-1

Req Title: Test Engineer V

Client: A major pharma company

Work Address: 20511 Lake Forest Drive, 92630, Lake Forest, CA

Duration: 18 Monthson W2

Hours per Week: 40.0

Position Summary:

Responsible for executing Client’s safety engineering strategy including support global market access and sustaining compliance for Client’s EM medical device portfolio. This role acts as SME for compliance requirements to standards both current and future and perform both in house and external testing during product development and verification and validation activities.

Evaluate, inform and deliver device and technical construction files and lead device evaluation activities using internal and external resources to ensure product safety compliance requirements meet all applicable standards.

Subject matter expert (SME) for IEC/ISO/EN/ANSI/AAMI sets of standards to inform product design teams throughout the product development lifecycle to ensure product launch and licensing milestones are met for all regions.

Leverage formal/informal presentations to cross-functional teams to ensure product requirements meet access requirements for 140 markets. To justify safety evaluations against an evolving, regional-based regulatory landscape, author and support position papers with engineering rationale.

Partner with the Client Global MTO to ensure all product lines fully comply with safety standards as well as market access and business requirements. Produce all technical reports to support audits.