Massachusetts Jobs

PURPOSE AND SCOPE:

This Senior Staff Software Engineer will play a key role in the design, development, testing, and support of next generation dialysis instruments at NxStage Medical. They will be collaborating with a diverse team of cross-disciplinary engineers and work in a dynamic and fast-paced environment. The ideal candidate will contribute at the architecture, design, and implementation stages, exhibiting outstanding verbal and written communication skills.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Provide technical leadership for product design, development, integration, testing, and reliability improvements on a major program

• Drive process and standards improvement efforts, provide mentoring to other software engineers

• Architect entire systems or major subsystems within the NxStage product line

• Conduct risk assessment activities for medical device software products

• Collaborate with electrical and mechanical engineers in the design of medical device products

• Work closely with the Project Management office to develop program schedules, and report out to Senior Management on status.

• Design and implement software for embedded devices and systems from requirements to production and commercial launch

• Design, develop, code, test, and debug system software following internal design control SOPs

• Support software Quality Assurance to meet the requirements of our internal Quality System, including specific requirements of GMPs, FDA QSR, IEC 62304, and ISO 9001 standards

• Collaborate with a diverse team of engineers to solve complex problems

• Conduct code reviews, create and maintain requirements and specification documents

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

• Support other software develop areas, including embedded processing / driver development, GUI development, algorithm development & implementation, alarm handling, and connectivity

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.

• May require lifting 2 to 10 lbs. Handling of heavier objects may be required on occasion.

EDUCATION AND REQUIRED CREDENTIALS:

• BS in Computer Science or Computer Engineering or equivalent in a technical/scientific field

EXPERIENCE AND SKILLS:

• 15+ years of relevant software product development experience

• Expert in Embedded C, C++ software development

• A solid understanding of embedded software, including: interrupts, ADCs, I2C, SPI, clock management, CAN

• Experience with Real Time Operating Systems, including porting a BSP to a new architecture

• Experience with low level driver implementation and advanced analog/digital signal processing

• Experience developing and debugging software on embedded processors utilizing JTAG or similar

• Demonstrated ability successfully leading software development efforts for complex medical device products

• Demonstrated ability to work independently and in small teams

• Demonstrated ability to act as technical lead for a team

• Strong analytical skills, with a desire to learn

DESIRED QUALIFICATIONS:

• Medical device or other safety critical device development

• Familiarity with FDA and international software development guidelines and standards

• Strong knowledge of project lifecycles, software development environments, and source control techniques

• Experience with automated software testing

• Previous experience troubleshooting circuit boards, including board bring-up and hands-on troubleshooting (e.g., oscilloscope, logic analyzer)

• Comfortable working with electronics schematics

• Experience writing control loops, algorithm development

• FPGA/CPLD programming experience

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.