The Staff Systems Engineer will play a key role in the design, development, testing, and documentation of next generation dialysis instruments at NxStage Medical. He or she will collaborate with a diverse team of engineers and work in a dynamic and fast-paced environment. This individual will lead systems engineering related activities on product development programs, exhibiting outstanding verbal and written communication skills.
- Leads the development and maintenance of system architecture, product specifications, requirements documents, build instructions, acceptance test specifications, V&V documentation, and other technical documentation.
- Provides technical leadership for product development, integration, testing, and reliability improvements.
- Leads a team of engineers and technicians to support product development as well as V&V activities in support of a regulatory filing.
- Maintain knowledge of state-of-the-art principles, theories, and practices around all systems engineering related activities. Identify and recommend long-term tools, standards, and methods to drive continual systems engineering improvement.
- Leads the development of algorithms, test plans, processes, test fixtures, data acquisition capabilities, etc., in support of on going product development as well as informal (dry run) and formal (design V&V) testing of complex electro-mechanical, software-driven medical devices; responsibilities may include managing parts flow, systems builds (including hardware assembly and integration), software loads and updates, configuration control, and test execution and reporting.
- Collaborates with a diverse technical team to create, update, and maintain documentation that is or will become part of the product design history file (DHF).
- Works with subsystem teams, domain subject matter experts, and suppliers in the identification, logging, assessment, and resolution of integration and test issues.
- Participates in Risk Management activities (including FMEA, FTA, OMA, etc.) to ensure that design and process needs are identified and appropriately addressed.
- Creates and reviews process, design, and fixture documentation including work guidelines, specifications, and CAD models / drawings.
- Applies knowledge of regulations and standards including: FDA design controls, ISO 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971.
- Role may include management responsibility for a team of engineers, programmers, technicians, and/or coops; responsibilities may include planning and directing / supervising employee activities, reviewing employee performance, identifying and supporting employee career development needs, etc.
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.
- Bachelor’s Degree in related engineering Biomedical Engineering, Electrical Engineering, Computer Science, or Mechanical Engineering (or equivalent in a technical/scientific field); MS/PhD preferred
EXPERIENCE AND REQUIRED SKILLS:
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
- 10+ years experience in Medical Device
- Strong understanding of medical device product design and regulatory processes.
- Able to communicate effectively, both verbally and in writing.
- Experience with medical device design and development processes that conform to standards including: ISO 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971.
- Strong understanding of system design, electronics, mechanical and software integration.
- Systems engineering experience (design product architecture development, requirements & specification development, risk management, V&V testing)
- Knowledge of design of experiments, six-sigma, and other statistics-based testing methodologies.
- Technical understanding of and experience with best-practice product development methodologies
- Experience with model based Systems Engineering and lifecycle management tool such as Enterprise Architect
- Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.
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