||Principal Systems Engineer
||Principal Systems Engineer – Product Development
The Principal 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 a new product development program, exhibiting outstanding verbal and written communication skills.
● Lead 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
● 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.
● Lead the development and maintenance of product specifications, requirements documents, hazards analysis documents, usability and V&V documentation, and other technical documentation.
● Lead 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 leadership for product design, development, integration, testing, and reliability improvements.
● 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.
||Education & Qualification:
● BS in Systems Engineering, Biomedical Engineering, Electrical Engineering, Computer Science, or Mechanical Engineering, MS preferred.
● 10+ years experience working as a Systems Engineer on product design, development, and/or testing; 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.
● Knowledge of design of experiments.
● Technical understanding of and experience with best-practice product development methodologies.
● Manufacturing experience
● Experience with design for manufacturing
NxStage Medical is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.
- 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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