Senior Design Verification Engineer

Laborie Medical Technologies Corp•Portsmouth, NH

About The Position

The Senior Design Verification Engineer leads lifecycle management and sustaining engineering initiatives for Laborie's capital medical equipment portfolio across Urology and Gastrointestinal product lines. The role drives product improvements, design changes, verification and validation activities, and regulatory compliance to maintain the safety, performance, and reliability of released products. Projects include Design History File updates, product and component modifications, failure investigations, production transfers, global regulatory registration support, and product obsolescence management. The engineer provides technical leadership while working with Quality, Regulatory Affairs, Manufacturing, Service, Product Development, and other cross-functional teams to deliver compliant, high-quality solutions that meet customer, clinical, and business needs and follow design control, risk management, and quality system requirements.

Requirements

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.
Strong analytical, problem-solving, and technical writing skills.
Excellent verbal and written communication skills and 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.
Eligible to work in the United States; the company will not sponsor work visas for this position at this time.

Nice To Haves

Working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, IEC 60601, IEC 62304, and related medical device standards.
Experience with Design History File maintenance, failure investigations, production transfers, and product obsolescence management.
Advanced skills with Altium and other CAD tools.

Responsibilities

Manage and support the lifecycle of existing capital medical equipment product lines, maintaining 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 teams to ensure new and modified products and processes meet design control and quality system requirements.
Provide technical support to Regulatory Affairs, Customer Care, Marketing, and Service for product issues, regulatory submissions, and country-specific registration activities.
Maintain and update Design History Files and other product records after 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 internal and external testing.
Conduct technical investigations, evaluate product performance data, and support root cause analysis and corrective action activities.
Develop and execute plans to address 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.
Perform other duties as assigned.