Senior Verification Engineer

Fresenius Medical Care•Lawrence, MA

20h•$134,202 - $140,912•Hybrid

About The Position

Senior Verification Engineer, Fresenius USA, Inc., a Fresenius Medical Care N.A. company, Lawrence, Massachusetts (Hybrid) 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 the engineering and product development of 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 project verification protocols, tracks test cases, engineering test reports, and position and/or white papers using good documentation practices. Analyzes test data and prepares and maintains verification documentation and compliance documentation as needed, including engineering change notices/protocols. Follows Food and Drug Administration (FDA)/International Standards Organization (ISO) Design Controls 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, establish and manage project specifications to ensure product system function, minimized patient risk and cost-effective manufacturing. Fosters culture of collaboration with CFT members, CTT members and departmental personnel. Assists with manufacturing validation processes in establishing product fabrication facilities and validation procedures. Maintains observation of production statistics to ensure production equipment and processes are effective and provides technical support to other departments as assigned. Provide mentoring and assistance to Engineer II and I level staff.

Requirements

Position requires either (i) a Bachelor’s degree (or an equivalent foreign degree) in Electrical or Electronics Engineering, System Engineering or a closely related field and 6 years of experience as a Verification Engineer in the design and manufacture of medical devices or (ii) a Master’s degree (or an equivalent foreign degree) in Electrical or Electronics Engineering, System Engineering or a closely related field and 4 years of experience as a Verification Engineer in the design and manufacture of medical devices.
Must also have 4 years of experience, which can have been gained concurrently with the primary experience requirement, working 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.
Salary is $134,202 – $140,912 per year for a 40-hour work week.

Responsibilities

Develops and maintains systems testing, and product enhancement strategies related to the engineering and product development of 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 project verification protocols, tracks test cases, engineering test reports, and position and/or white papers using good documentation practices.
Analyzes test data and prepares and maintains verification documentation and compliance documentation as needed, including engineering change notices/protocols.
Follows Food and Drug Administration (FDA)/International Standards Organization (ISO) Design Controls 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, establish and manage project specifications to ensure product system function, minimized patient risk and cost-effective manufacturing.
Fosters culture of collaboration with CFT members, CTT members and departmental personnel.
Assists with manufacturing validation processes in establishing product fabrication facilities and validation procedures.
Maintains observation of production statistics to ensure production equipment and processes are effective and provides technical support to other departments as assigned.
Provide mentoring and assistance to Engineer II and I level staff.