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PURPOSE AND SCOPE

The Service Systems Engineer II will play a key role in supporting service user needs for the design, development, testing, and documentation of dialysis instruments at NxStage Medical. He or she will collaborate with a diverse team of cross-functional roles, such as engineering, manufacturing, and product development, and work in a dynamic and fast-paced environment. This individual will support service engineering related activities on product development programs, exhibiting outstanding verbal and written communication skills.

PRINCIPAL DUTIES AND RESPONSIBILITIES

● Support service engineering efforts for a complex, software-driven medical device; responsibilities may include defining spare parts requirements, reviewing systems builds (including hardware assembly and integration) for adherence to design for serviceability standards, managing software load and update processes, configuration control, and test execution and reporting.

● Collaborate with a diverse technical team to create, update, and maintain service documentation that is or will become part of the product design history file (DHF) for various dialysis products.

● Support the development and maintenance of product specifications, requirements documents, hazards analysis documents, usability and V&V documentation, and other technical input required for service documentation content development.

● Conduct Risk Management activities to ensure that design and process shortcomings are identified and appropriately addressed.

● Provide technical guidance for product design, development, integration, testing, and serviceability and reliability improvements.

● Collaborates with R&D to identify and develop resolutions for design issues/defects reported during field service and equipment use activities

● 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 up to 50 lbs. Handling of heavier objects may be required on occasion.

EDUCATION AND REQUIRED CREDENTIALS

● BS in Biomedical Engineering, Mechanical Engineering), Systems Engineering, Electrical Engineering, or Computer Science (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 medical device products is preferred.

● Dialysis industry experience preferred.

● Understanding of medical device product design, serviceability 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, IEC 62353, 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

● Medical device service delivery experience

● Experience with design for serviceability

● Manufacturing experience

● Experience with design for manufacturing