Design Verification Engineer, PLM

Laborie Medical Technologies Corp•Portsmouth, NH

About The Position

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, procedures for products, design changes, DHF & DMR updates, support to country-specific registration requirements, failure investigations, design transfers, and product obsolescence management.

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 applicable standards/regulations such as GMP, FDA's QSR (CFR 820), IEC 60601 and /or IEC 62304 EU MDD/EU MDR, and ISO 13485, and 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.
Must be 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 "hands-on" approach to engineering.

Nice To Haves

Knowledge of Azure DevOps, JIRA, Greenlight Guru, or other test environment, SAP Business applications a plus

Responsibilities

Assist in managing the product life cycle of released product lines.
Initiate, manage and deliver product changes to support sales, marketing, production, and service.
Collaborate 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.
Provide technical support to regulatory affairs, customer care, and marketing staff for product support issues and country registration processes.
Communicate and follow up on project details, milestones and expected outcomes to subcontractors.
Maintain Design History Files and Device Master Records and other related documents, following product launch in accordance with company policy and procedures.
Prepare test validation protocols, testing, results analysis, and report writing for product and/or process changes, including both internal and external testing.
Develop and execute plans to address gaps and deficiencies, whether identified internally or as audit non-conformances.