Senior Design Verification Engineer
- Compensation
- Not disclosed
- Location
- Portsmouth, United States
- Work setup
- Not specified
- Seniority
- Senior
- Employment
- Not specified
- Experience
- Not specified
- Category
- Design
- Posted
Skills
Nice to have
- 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 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.
Full description
We believe that great healthcare is an essential safeguard of human dignity.
At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you.
We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We’re not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We reward and recognize our employees based on our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion.
Who We’re Looking For:
The Senior Design Verification Engineer is responsible for leading 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, the Senior Design Verification Engineer provides technical leadership to deliver compliant, high-quality solutions that meet customer, clinical, and business needs while ensuring adherence to design control, risk management, and quality system requirements.
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.