Staff Validation Engineer

About the Role

Draeger Medical Systems, Inc. in Andover, MA seeks a Staff Validation Engineer to lead test planning, strategy, and documentation for assigned projects and products. This role involves providing advice on verification decisions impacting cross-functional teams, anticipating product-level quality issues, and proactively identifying gaps in test coverage, protocol compliance risks, and integration risks in regulated development environments.

Responsibilities

• Design and develop test strategies, procedures, and automation scripts for verifying and validating products through automated and manual testing approaches, 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.
• Manage and resolve verification roadblocks efficiently, engaging cross-functional stakeholders as necessary.
• Document deviations in the 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 hazard mitigation 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 provide feedback to cross-functional teams on customer problems or needs, partnering with requirements owners to ensure all stakeholder perspectives are addressed.
• Produce test reports, summaries, and technical documentation to support product release to production, including reporting for product lifecycle management.
• 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.
• Mentor and guide other engineering team members on verification best practices, providing technical guidance and thorough documentation.
• Facilitate cross-team collaboration 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.
• Travel 5% domestically and/or internationally to provide and obtain cross-training and meet with co-workers.

Qualifications

Requires a Master’s degree (or foreign equivalent) in Engineering Management, Mechanical Engineering, or a related field and three (3) years of experience in the job offered or a related role. Alternatively, a Bachelor’s degree (or foreign equivalent) in Engineering Management, Mechanical Engineering, or a related field and five (5) years of post-degree, progressive experience in the job offered or a related role is acceptable.

Skills

• Project test leadership and functional test planning in regulated development environments (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.
• Creating technical documentation and reporting for product lifecycle management.

Pay

$135,325 per year.

Benefits

• Medical, dental, and vision insurance.
• Life, short-term, and long-term disability coverage.
• 401(k) with company match.
• Over 4 weeks of paid time off, plus holidays and parental leave.
• Flexible spending accounts and employee assistance program.
• Select locations offer free parking, an on-site gym, cafeteria, and game room.

About the Company

Draeger is guided by the principle “Technology for Life” and has several sites across North America, including headquarters in Telford, PA, and locations in Andover, MA, Houston, TX, and Mississauga, Ontario. The company is an Equal Opportunity Employer.