Sr. Verification Engineer, Fresenius USA, Inc., a Fresenius Medical Care N.A. company, Lawrence, Massachusetts.

Will serve as a resource and key technical expert to support related projects and provide production verification support to ensure product reliability, dependability and efficient manufacturability. Will be responsible for performing high level tasks and working independently to organize work between required Cross Functional Teams (CFTs). Will also formulate new verification research projects, starting with a concept, formulating a pre-development plan and completing a feasibility/validation study. Specific duties and responsibilities will include:

• Develops, and maintains systems testing, and product enhancement strategies related to class II medical devices.
• Fulfills subject matter expert role with systems verification at all stages from converting lab scale technology into a commercial medical product to supporting the released product.
• Authors verification plans, test cases, verification protocols, engineering test reports, and position and/or white papers using good documentation practices.
• Analyze test data and prepare and maintain verification documentation and compliance documentation as needed, including engineering change notices/protocols.
• Follows Food and Drug Administration (FDA)/International Standards Organization (ISO) Design Control principles and regulations in product verification and development.
• Designs and develops products that meet user inputs and support business and marketing strategies to further generate revenue growth.
• Applies risk-based procedures throughout the product development verification process and the product life cycle.
• Works closely with Engineering to develop and establish detailed Design input specifications to ensure product function, minimized patient risk and cost-effective manufacturing.
• Works closely with CFT and CTT teams to understand defect management and achieve defect resolution to ensure high quality products.
• Executes verification projects and protocols with clear objectives and timely deliverables and understands the goals and contents of development and research projects.
• Fosters culture of collaboration with CFT members, CTT members and departmental personnel.
• Provides assistance to manufacturing in establishing product fabrication facilities and validation procedures as part of Design Transfer.
• Maintains observation of production statistics to ensure production equipment and processes are effective and provides technical support to other departments as assigned.
• Responsible for lab layout and expansion including building test bench and test figures, and handling material purchasing and lab inventory management.
• Hands-on prototype assembly, testing, data analysis and trouble shooting electronic circuitry, hydraulic, and/or pneumatic systems.

Requirements:

Position requires either (i) a Bachelor’s degree (or an equivalent foreign degree) in Biomedical, Electrical or Industrial Engineering or a closely related field and 6 years of experience as a Verification Engineer in the medical device sector or (ii) a Master’s degree (or an equivalent foreign degree) in Biomedical, Electrical or Industrial Engineering or a closely related field and 4 years of experience as a Verification Engineer in the medical device sector.

Must also have 4 years of experience (which can have been gained concurrently with the primary experience requirement above) with the following:

• Regulatory (FDA) and applicable standards (ISO 13485 and ISO 14971);

• Analyzing component, software, and system requirements to develop, edit, and update test plans, protocols, and reports following the appropriate design control process;

• Conducting and documenting verification plans and reliability plans and corresponding protocol, and report reviews;

• Evaluating system interfaces, operational requirements, performance requirements, and software tests;

• Developing, identifying, implementing, validating, and deploying test methods and test automation solutions; and

• Performing defect management and defect resolution;

This is a hybrid position working 4 days/week at the office in Lawrence, MA and 1 day/week from home.