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Fresenius Medical Care North America System Verification Lead in Lexington, Massachusetts

Position is a Hybrid position (20% onsite in Lexington, MA; 80% remote)

PURPOSE AND SCOPE:

The System Verification Lead works largely unsupervised. The lead is involved in mentoring and teaching subordinate department or group members in order to improve their product knowledge, subject matter understanding, skills and productivity. The lead also will be involved in setup of strategic activities, process improvements, and specific scientific studies for research and development. The lead will often be a team leader of either internal Cross Technical Teams (CTT) or external Cross Functional Teams (CFT) and responsible to drive associated projects to completion. The lead can also serve in a consultant role in multiple functional teams. The Staff Engineer functions as a Subject Matter Expert (SME) on the respective products and disciplines in which he/she is trained and expert in and may be assigned to manage various aspects of products from development, changes, improvements, replacements, etc.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

  • Works as a team leader to design, develop and modify Software verification plans, protocols and reports for multiple projects by analyzing software requirements and following the appropriate software development process. Awareness of GDocP is preferred.

  • Executes test protocols, and writes reports to describe program evaluation, testing, and correction.

  • Acts as primary technical contact in the company to provide decisions and recommendations for software verification aspects of projects.

  • Leads software verification plans and protocol reviews and other related design reviews.

  • Works with product development teams to evaluate system interfaces, operational requirements, and performance requirements, and testability software.

  • Creates, identifies, validates, and uses test tools that facilitate data gathering and test method execution.

  • Leads the design, build, validation and deployment of effective test automation solutions.

  • Understands defect management and works closely with Software Engineers on defect resolution.

  • Maintains effective communication with the project manager, and team members on project scope, timelines, and design changes.

  • Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.

  • Manages multiple teams of software verification engineers based at offshore for their quality output and resource allocation

  • Acts as key contributor to the setup and following best practices of Test Management Center of Excellence within Digital Services and Solutions (DSS)

  • Analyses and drives key initiatives focusing on non-functional testing of the software solutions

  • Determines methods and procedures on new assignments and may coordinate activities of other personnel (Team Lead).

Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.

PHYSICAL DEMANDS AND WORKING CONDITIONS :

  • The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Potential travel up to 10%.

EXPERIENCE AND REQUIRED SKILLS :

  • Bachelor’s Degree in related engineering or scientific discipline required; Advanced Degree preferred.

  • Minimum 8 years’ related experience.

  • Demonstrated understanding of principles, theories and concepts in the software engineering field, preferably in the medical device area.

  • Software verification experience in a product development environment.

  • Experience with C, or assembly-level code development, embedded processing and I/O control.

  • Experience in development of automated test platforms and scripts.

  • Excellent analytical skills.

  • Experience using tools to test and troubleshoot software applications.

  • Excellent organizational and verbal/written communication skills.

  • Strong interpersonal skills with ability to work effectively in a team.

  • High level of initiative with ability to self-manage.

  • Highly motivated and energetic. Passion for creating high quality medical device software.

  • Experience and familiarity with ISO 13485 and IEC 62304, and with FDA GMP is preferred.

  • Experience with sensors, microprocessor/microcontroller and/or FPGA based digital design is preferred.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.

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