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 from the EGBC preferred; ability and willingness to obtain a P.Eng license required*
• 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