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Fresenius Medical Care North America Principal Software Design Assurance Engineer in Lawrence, Massachusetts

Job ID 2100005E

Available Openings 1

Position Summary:

As a key member of the Software Design Assurance Group, the engineer will support the activities related to the design, development, and ongoing maintenance of software-based medical device products and supporting software.

Core Responsibilities:

  • Provides quality oversight and guidance for Software Design and Development, for product and non-product software.

  • Review deliverables of the development lifecycle for correctness and compliance to policies. Includes requirements management, configuration management, issue tracking, design verification and validation.

  • Lead root cause analysis activities to resolve Software Quality-related problems

  • Lead/support Risk Management activities to ensure software design and process shortcomings are identified and appropriately addressed

  • Support the product development teams in the adoption and use of best practices, Quality tools, and Software Design Control methodologies

  • Strong analytical and problem-solving skills, ability to multitask in an environment with changing priorities

  • Investigate/reproduce customer problems/issues

  • Work with other Groups to maintain an approved internal Quality System that meets medical device quality system regulations and standards

  • Support CAPA investigations and other quality activities as needed.


  • 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.

  • Extended computer-based work in an office environment.


  • Bachelor’s Degree or higher in Computer Science, Software Engineering, or related field required.

  • Master’s Degree in compute related field preferred.


  • 10+ years related Software Quality Assurance/Quality Engineering experience

  • Working knowledge of FDA Quality System Regulation 21 CFR Part 820, General Principles of Software Validation, IEC62304, and ISO13485 required.

  • Excellent verbal communication and technical writing skills

  • Ability to interface with multiple groups in the organization.

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.