||Sr. Systems Engineer - Product Development
||Senior Systems Engineer – Product Development
The Senior 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 (or equivalent in a technical/scientific field); MS preferred.
● 7+ 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
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