PURPOSE AND SCOPE:

The Systems Engineer II will play a key role in supporting the design, development, testing, and documentation of 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 support systems engineering related activities on product development programs, exhibiting outstanding verbal and written communication skills.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Support systems engineering efforts for a complex, software-driven medical device; responsibilities may include managing parts flow, systems builds (including hardware assembly and integration), software loads and updates, configuration control, and test execution and reporting.
• Collaborate with a diverse technical team to create, update, and maintain documentation that is or will become part of the product design history file (DHF) for a home dialysis instrument.
• Support the development and maintenance of product specifications, requirements documents, hazards analysis documents, usability and V& V documentation, and other technical documentation.
• Conduct Risk Management activities to ensure that design and process shortcomings are identified and appropriately addressed.
• Perform Risk Analyses, including Fault Tree Analysis (FTA), Operator Misuse Analysis (OMA), and Failure Mode and Effects Analysis (FMEA) activities.
• Work with subsystem teams, domain subject matter experts, and suppliers in the identification, logging, assessment, and resolution of integration and test issues.
• Provide technical guidance for product design, development, integration, testing, and reliability improvements.
• Owns and drives resolution of design issues/defects, under guidance from senior R& D engineers
• Performs product tests to conform compliance to regulatory standards.
• Works on problems of moderate scope where analysis of situation or data requires a review of a variety of factors.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Respond rapidly and flexibly to emerging issues in production, quality, engineering, or supply chain.
• Create and review process, design, and fixture documentation including work guidelines, specifications, and CAD models / drawings.

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 Systems Engineering, Biomedical Engineering, Electrical Engineering, Computer Science, or Mechanical Engineering (or equivalent in a technical/scientific field); MS preferred.

EXPERIENCE AND SKILLS:

• 2+ years experience working as a Systems Engineer on product design, development, and/or testing; experience with class II medical device products is preferred.
• 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.
• Knowledge of design of experiments.
• Technical understanding of and experience with best-practice product development methodologies.

Desired Qualifications:

• Manufacturing experience
• Experience with design for manufacturing

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.