Senior Test Engineer

at  Verathon

Company Overview:
Verathon is a global medical device company focused on supporting customers by being their trusted partner, delivering high-quality products that endure over time and ensure clinical and economic utility. Two areas where Verathon has significantly impacted patient care, and become the market leader in each, are bladder volume measurement and airway management. The company’s BladderScan portable ultrasound and GlideScope video laryngoscopy & bronchoscopy systems effectively address unmet needs for healthcare providers and meaningfully raise the standard of care for patients. Verathon, a subsidiary of Roper Technologies, is headquartered in Bothell, Washington, USA and has international subsidiaries in Canada, Europe and Asia Pacific. For more information, please visit www.verathon.com.
Overview:
The Senior Test Engineer is responsible for supporting new product development (NPD) programs by delivering product design verification (DV). This role closely interacts with other cross-functional teams including design, manufacturing, quality, regulatory, and program management.

Responsibilities:

• Manage and complete DV activities for multiple NPD programs
• Develop DV project plan based on program scope, including deliverables, timelines, and resource needs
• Identify, ideate, and oversee development of, novel engineering test methods and fixtures for DV
• Identify, and oversee development of, verification plans, protocols, and reports
• Peer-review and provide feedback on team deliverables for technical soundness and audit-readiness
• Oversee technical and schedule communication with internal and external partners to manage and retire risks efficiently
• Collaborate with test engineers, design engineers, and cross-functional teams to analyze product test failures and recommend solutions
• Provide critical updates to the management including Test and Design Engineering Managers
• Develop and maintain subject matter expertise in applicable technical standards for medical device development e.g., ISO 10993, ISO 8600, and IEC 60601-1
• Identify and implement improvements to the verification test system via e.g., standardization, tools, and automation
• Ensure deliverables comply to applicable regulatory standards e.g., ISO 13485, 21 CFR part 820, and 21 CFR Part 11
• Follow Verathon’s Quality Management System and documentation practices
• Ensure completion of tasks within project schedule and with high attention to detail

Qualifications:

• Bachelor’s degree in engineering (mechanical, mechatronics, or similar); Advanced degree preferred
• P. Eng. registration with EGBC
• 8+ years of test/design/systems engineering experience in a product development environment, some of which is within medical device R&D
• Strong analytical foundation, using engineering principles for problem-solving during NPD
• Hands-on experience developing and qualifying engineering test methods & tools
• Hands-on experience with developing electromechanical systems and root cause analysis
• Experience managing and delivering design verification in a highly regulated industry
• Experience using project planning tools and concepts
• Experience using statistical techniques, preferably using Minitab
• Proficient in writing concisely and accurately with meticulous attention to detail and clarity
• Strong verbal and written communication skills, suited for a cross-functional environment
• Ability to work within tight deadlines with transparent communication
• Familiar with CAD tools and microcontrollers (e.g. Arduino); hands-on experience preferred
• Familiar with medical device applicable technical and regulatory standards e.g., ISO 10993, ISO 8600, and IEC 60601-1, 21 CFR Part 11; hands-on experience preferred
• Experience with Jama (for requirements management) and Jira (for issue tracking) preferred

• Manage and complete DV activities for multiple NPD programs
• Develop DV project plan based on program scope, including deliverables, timelines, and resource needs
• Identify, ideate, and oversee development of, novel engineering test methods and fixtures for DV
• Identify, and oversee development of, verification plans, protocols, and reports
• Peer-review and provide feedback on team deliverables for technical soundness and audit-readiness
• Oversee technical and schedule communication with internal and external partners to manage and retire risks efficiently
• Collaborate with test engineers, design engineers, and cross-functional teams to analyze product test failures and recommend solutions
• Provide critical updates to the management including Test and Design Engineering Managers
• Develop and maintain subject matter expertise in applicable technical standards for medical device development e.g., ISO 10993, ISO 8600, and IEC 60601-1
• Identify and implement improvements to the verification test system via e.g., standardization, tools, and automation
• Ensure deliverables comply to applicable regulatory standards e.g., ISO 13485, 21 CFR part 820, and 21 CFR Part 11
• Follow Verathon’s Quality Management System and documentation practices
• Ensure completion of tasks within project schedule and with high attention to detai