Design Verification Engineer, PLM
Laborie · Portsmouth, NH · 1 wk ago
On-siteEngineeringFull-time
About the Role
As a key member of the R&D PLM Engineering team, the Design Verification Engineer is responsible for various engineering activities to support ongoing improvements and maintenance of current product lines in the Laborie Portfolio. This includes:
- Detailed design verification documents, testing, and integration of software/hardware/firmware components, product assemblies, and procedures for products
- Design changes, DHF & DMR updates
- Support to country-specific registration requirements
- Failure investigations, design transfers, and product obsolescence management
- Managing the product life cycle of released product lines
- Initiating, managing, and delivering product changes to support sales, marketing, production, and service
- Collaborating with new product development, manufacturing engineering, and quality engineering staff to ensure compliance of new or modified products and processes to company design control and quality system requirements
- Providing technical support to regulatory affairs, customer care, and marketing staff for product support issues and country registration processes
- Communicating and following up on project details, milestones, and expected outcomes to subcontractors
- Maintaining Design History Files and Device Master Records and other related documents following product launch in accordance with company policy and procedures
- Preparing test validation protocols, testing, results analysis, and report writing for product and/or process changes, including both internal and external testing
- Developing and executing plans to address gaps and deficiencies, whether identified internally or as audit non-conformances
Requirements
- Bachelor’s degree in engineering – System, Electrical/Electronic, Mechanical, and/or Biomedical or equivalent
- 2+ years' experience in design, development, and testing in Medical, Automotive, Aerospace, or similar industries
- Knowledge of Azure DevOps, JIRA, Greenlight Guru, or other test environment, SAP Business applications (a plus)
- Knowledge of applicable standards/regulations such as GMP, FDA's QSR (CFR 820), IEC 60601 and/or IEC 62304, EU MDD/EU MDR, and ISO 13485
- Understanding of test method verification, validation, and analytical methods
- Good understanding of/familiarity with engineering concepts including design for excellence, CTQ design and development, and engineering change process
- Highly organized with well-developed time-management skills and the ability to manage multiple priorities simultaneously in a rapidly changing environment
- Excellent communication skills, attention to detail, commitment to quality, ability to work on multiple projects concurrently, and technical aptitude with a "hands-on" approach to engineering
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
Awarded 2025 Cigna Healthy Workforce Designation Gold Level.