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
