Senior Design Verification Engineer

The Senior Design Verification Engineer leads lifecycle management and sustaining engineering initiatives for Laborie's capital medical equipment portfolio across Urology (UR) and Gastrointestinal (GI) product lines. This role drives product improvements, design changes, verification and validation activities, and regulatory compliance efforts to ensure the continued safety, performance, and reliability of released products. The engineer leads Design Verification projects including Design History File (DHF) updates, product and component modifications, failure investigations, production transfers, global regulatory registration support, and product obsolescence management, working closely with cross-functional teams including Quality, Regulatory Affairs, Manufacturing, Service, and Product Development.

About the Role

• Manage and support the lifecycle of existing capital medical equipment product lines, ensuring continued performance, quality, reliability, and regulatory compliance.
• Design, implement, verify, and deliver product and process changes that support sales, marketing, manufacturing, service, and customer requirements.
• Collaborate with New Product Development, Manufacturing Engineering, Quality Engineering, and other cross-functional teams to ensure new and modified products and processes comply with design control requirements and quality system regulations.
• Provide technical support to Regulatory Affairs, Customer Care, Marketing, and Service teams for product-related issues, regulatory submissions, and country-specific registration activities.
• Maintain and update Design History Files (DHF) and other product records following product launch in accordance with company policies, procedures, and regulatory requirements.
• Lead or prepare verification and validation protocols, test execution, data analysis, and technical reports for product and process changes, including both internal and external testing activities.
• Conduct technical investigations, evaluate product performance data, and support root cause analysis and corrective action activities as needed.
• Develop and execute plans to address identified gaps, deficiencies, quality issues, and audit observations, including internal findings and external non-conformances.
• Provide technical leadership and mentorship to junior engineers and project teams while supporting cross-functional project execution.
• Support continuous improvement initiatives focused on product quality, reliability, manufacturability, compliance, and operational efficiency.

Qualifications

• Bachelor's degree in Systems, Electrical, Electronics, Mechanical, Biomedical Engineering, or a related engineering discipline.
• Minimum 8 years of experience in design verification, product development, testing, and lifecycle management of medical devices or other regulated products.
• Experience leading design verification, product change, and PLM projects for complex medical devices or capital equipment.
• Strong understanding of manufacturing processes, design controls, risk management, and engineering change processes.
• Working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, IEC 60601, IEC 62304, and related medical device standards preferred.
• Experience with Design History File (DHF) maintenance, failure investigations, production transfers, and product obsolescence management.
• Advanced skills with Altium and other CAD tools are a plus.
• Strong analytical, problem-solving, and technical writing skills.
• Excellent verbal and written communication skills with the ability to collaborate across cross-functional teams.
• Highly organized, self-motivated, and able to manage multiple priorities in a fast-paced environment.
• Demonstrated ability to provide technical leadership, mentorship, and independent decision-making.

Benefits

• Paid time off and paid volunteer time
• Medical, Dental, Vision and Flexible Spending Account
• Health Savings Account with Company Funded Contributions
• 401k Retirement Plan with Company Match
• Parental Leave and Adoption Services
• Health and Wellness Programs and Events