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:
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.
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.