Staff Validation Engineer

The Job Responsibilities

Draeger Medical Systems, Inc., Andover, MA seeks Staff Validation Engineer - Leading test planning, strategy, and documentation for assigned project and product, providing advice on verification decisions that impact cross-functional teams and functional test planning in regulated development environments and anticipate product-level quality issues and proactively identify gaps in test coverage, protocol compliance risks, and integration risks. Designing and developing test strategies, procedures, automation scripts for verifying and validating products through automated and manual testing approaches, working on multiple projects concurrently and balancing priorities across design changes, product releases, and regression campaigns. Investigate equipment failures and difficulties to diagnose faulty operation, perform root cause analysis and recommend remedial actions for electromechanical and software systems, and manage and resolve verification roadblocks efficiently, engaging cross-functional stakeholders as necessary. Documenting deviations in our deviation tracking database for observed issues and provide early troubleshooting to capture initial diagnostics for the development team in tracking tools. Produce hazard mapping and risk tracing based on safety-critical product hazard descriptions, develop test strategies and procedures to verify that identified hazards have been properly mitigated in accordance with regulatory compliance requirements, identify and communicate broader project and system risks in collaboration with cross-functional stakeholders. Perform product validation planning and providing feedback to the cross-functional team on customer problems or needs, partnering with requirements owners to ensure all stakeholder perspectives are addressed. Producing test reports, summaries and technical documentation to support the product’s release to production including reporting for product lifecycle management and articulate the impact of verification decisions on other subsystems, disciplines, and project timelines. Serve as the subject matter expert on verification processes, leading technical discussions, communicating decisions and standards through design reviews and team forums, and proactively identify technical challenges and propose solutions through cross-functional collaboration. Mentor and guide other engineering team members on verification best practices, making others better through technical guidance, and thorough documentation, and facilitate cross-team collaboration as a force multiplier by coordinating verification activities across software, hardware, and systems teams. Research and evaluate new testing technologies and methodologies to improve verification efficiency, reducing process complexity and increasing overall test coverage. Will travel 5% US and/or Int’l to provide and obtain cross training and meet with co-workers.

Your Qualifications

Requires Master’s  (or foreign educ. equiv.) in Engineering Management, Mechanical Engineering or related field and three (3) yrs. experience in Job Offered or related.  Alternatively, will accept a Bachelors (or foreign educ. equiv.) in Engineering Management, Mechanical Engineering or related field and five (5) yrs. (post-degree, progressive) experience in Job Offered or related.  Experience must have included Project test leadership and functional test planning in regulated development environments including ISO 13485; Creating automated and manual tests for end-to-end product validation; Performing diagnostic and root cause analysis in electromechanical and software systems; Deviation management and early-stage troubleshooting using tracking tools; Hazard analysis and risk tracing for safety-critical products; Test development for hazard mitigation and regulatory compliance verification; Validation planning and cross-departmental technical communication; and Experience in creating technical documentation and reporting for product lifecycle management. $135,325/yr.

Send resume to amy.covely@draeger.comand must refer to Reference #1328