Service Systems Engineer II

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 fie...