Lead Validation Engineer - Medical Devices (Hybrid)

emplify GmbH; Andover (MA); Hybrid; USD 120,000 - 150,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Paid time off & holidays

Job summary

Draeger Medical Systems, Inc., Andover, MA, seeks a Staff Validation Engineer to lead test planning, strategy, and documentation for regulated development projects. You will advise on verification decisions, design and develop test strategies, and manage multiple projects with cross-functional teams to ensure quality and compliance.

You will also design and develop both automated and manual tests, investigate failures, and perform root cause analysis while maintaining hazard mapping and risk

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.
• Alternative: Bachelor’s (or foreign educ. equiv.) inEngineering Management, Mechanical Engineering or related field and five (5) yrs. experience.
• Experience in ISO 13485, test development for hazard mitigation, and cross-departmental communication.

Responsibilities

• Lead test planning, strategy, and documentation for assigned project.
• Develop test strategies, procedures, and automation scripts.
• Perform root cause analysis for failures in electromechanical and software systems.
• Manage and resolve verification roadblocks with cross-functional teams.
• Produce hazard mapping and risk tracing to mitigate safety hazards.

Skills

Project test leadership

Functional test planning

Regulated development environments

Test automation concepts

Root cause analysis

Hazard analysis & risk tracing

Debugging diagnostics

Documentation & reporting

Cross-functional collaboration

Education

Master’s degree in Engineering Management

Bachelor’s degree in Engineering Management

Tools

Automated testing frameworks

Deviation tracking tools

Job description

Draeger Medical Systems, Inc., Andover, MA, seeks a Staff Validation Engineer to lead test planning, strategy, and documentation for regulated development projects. You will advise on verification decisions, design and develop test strategies, and manage multiple projects with cross-functional teams to ensure quality and compliance.

You will also design and develop both automated and manual tests, investigate failures, and perform root cause analysis while maintaining hazard mapping and risk