Senior Design Verification Engineer

Laborie Medical Technologies Corp; Portsmouth (NH); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Paid time off

Medical, Dental, Vision coverage

Health Savings Account (HSA)

401k with company match

Parental Leave

Job summary

Laborie is seeking a Senior Design Verification Engineer to lead lifecycle management for capital medical equipment in UR and GI lines. You will drive design verification, DHF updates, and product changes while ensuring regulatory compliance and collaboration with Quality, Regulatory, Manufacturing, Service, and Product Development teams.

You will provide technical leadership, mentor junior engineers, and support continuous improvement in product quality and manufacturability in a fast-paced

Qualifications

• Lead design verification and DHF updates.
• Ensure design controls and quality system compliance.
• Strong analytical and technical writing skills.
• Mentor junior engineers and drive cross-functional projects.
• Regulatory standards knowledge (FDA QSR, ISO 13485) preferred.

Responsibilities

• Manage lifecycle of existing capital medical equipment product lines.
• Design, verify, and deliver product and process changes that meet requirements.
• Collaborate with cross-functional teams to ensure compliance with design controls.
• Provide technical support for regulatory submissions and country registrations.
• Lead verification/validation protocols and technical reports.

Skills

Design verification

Product development

Testing

Lifecycle management

Regulatory compliance

PLM

Altium CAD

Technical writing

Cross-functional collaboration

Education

Bachelor’s degree in engineering

Tools

Altium

Job 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.
• 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.
• Perform other duties as assigned.

Preferred 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 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.

Why Laborie:

Our Mission every day is to operate as a world‑class specialist medical company making and advancing technologies that preserve and restore human dignity. We do that today by helping people with pelvic and gastrointestinal conditions live normal lives, and by helping mothers and babies have safe deliveries.

• 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

We are interested in a qualified candidate who is eligible to work in the United States. However, we will not be sponsoring work visas for this position, at this time.

Laborie provides equal employment opportunities and non‑discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Laborie is committed to providing access and reasonable accommodation in our services, activities, education, and employment for individuals with disabilities.