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Job Description

Job ID tbd Available Openings 1

PURPOSE AND SCOPE:

Will participate in the design, development, testing, and support of the cybersecurity architecture supporting the development of next generation dialysis instruments at NxStage Medical. Will implement procedures at the architecture, design, and implementation stages to develop embedded systems cybersecurity.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Apply state-of-the-art methods to create software systems for NxStage products, developing improvements to existing security designs.

• Apply the principles of software configuration management, software life cycle, and software maintainability to cybersecurity implementations and improvements.

• Participate in multidisciplinary teams, including collaborating with other engineers to solve complex problems.

• Investigate the feasibility of new projects, systems, or approaches.

• Create requirements and draft specification documents.

• Create and execute unit tests as part of software validation efforts.

• Provide technical support for product research, design & development, integration, and testing.

• Create product use cases, story boards, and interaction process flows.

• Develop software architecture and code to support secure user interactions.

• Support usability testing and human factors engineering, including working with customers to create and refine robust user interfaces.

• Develop software in multiple levels and areas, including embedded processing/driver development, Real Time Operating System (RTOS) integration, cybersecurity, Graphical User Interface (GUI) development, algorithm development & implementation, alarm handling, and connectivity.

• Assist in debugging existing designs and developing reliability improvements.

• Follow Design Control Standard Operating Procedures (SOPs) for projects and programs, including following the software development lifecycle.

• Work with Quality Assurance to meet the requirements of our internal Quality System, including specific requirements of Good Manufacturing Practices (GMPs), FDA Quality System Regulations and relevant International Electrotechnical Commission (IEC) standards including 62304, and ISO 13485.

EDUCATION and LICENSURE:

• Bachelor’s degree (or an equivalent foreign degree) in Computer Science, IT or a closely related field

EXPERIENCE AND REQUIRED SKILLS:

7 years of experience as a software product engineer. Must also have 5 years of experience (which can have been gained concurrently with the primary experience requirement above) working with the following:

• Designing and developing at all phases of the software development lifecycle;

• C and C++;

• Working with Real Time Operating Systems, writing embedded device drivers and developing and debugging software on embedded processors utilizing JTAG or similar tools;

• Secure development lifecycle best practices and designing and developing cybersecurity software applications used in medical devices or other regulated products;

• TCP/IP Networking, Routing and Cloud Software application development;

• Pen testing and fuzz testing as well as the principles of software design for security; and

• Writing and reviewing cyber security analysis and threat modelling documentation and proposing and implementing a threat mitigation plan.

Please note that this is a hybrid position working 3 days/week from the company’s office in Lawrence, Massachusetts and 2 days/week at a home office.

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.