||Principal Systems Engineer
The Principal Systems Engineer will play a key role in the development 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 engineering development, design verification and validation testing activities on a new product development program and manage a small team .
● Leads the development and maintenance of 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.
● 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) for a home dialysis instrument.
● 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 small 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.
||Education & Qualification:
● BS in Systems Engineering, Biomedical Engineering, Electrical Engineering, Computer Science, or Mechanical Engineering (or equivalent in a technical/scientific field); MS preferred.
● 7+ years experience with V&V testing and/or product development under FDA design controls and ISO13485; experience with class II medical device products is preferred.
● 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 (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.
● Prior management experience
● Manufacturing and DFM experience
- Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.
- Please view Equal Employment Opportunity Posters provided by OFCCP
- The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access
to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure
is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41
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