The Systems Engineer is responsible for solutions, architecture, and requirements management of an electronic medical device system. This position leads collaboration efforts for requirements analysis and test documentation, including all related Requirements Specification, Design Description, Test Plan and Test Procedures. Facilitate System Design, System Verification and Validation Strategies in cooperation with other engineering functions for end-user products, in-house products, or any other products needing system coordination i.e., engineering tools, manufacturing tools. Identify, mitigate, and manage technical risk as part of the design oversight process. Provide technical insight to Regulatory, Clinical, or Manufacturing to support regulatory, clinical, or manufacturing strategies.
Reporting to the Director of Systems Engineering, you will lead and drive our Engineering capabilities across several important development projects that will potentially impact millions of patients! If you think you have what it takes and really want to make a difference - we would love to hear from you!
Brief description of job duties:
- Works with business development, clinical, regulatory, and engineering to define user needs and systems requirements.
- Enters and maintain requirements in Jama. Will help engineering properly decompose system requirements into device and component requirements such that all requirements are testable.
- Works with QA to develop risk analysis and FMEAs. Will work with clinical and engineering to develop tests to find and characterize emergent behaviors. Solicit the regular review of others on all work products.
- Work closely with all departments to ensure timely delivery of a quality product.
Education and Experience:
- BS in electrical or biomedical engineering (MS desired).
- 5+ years of experience in product development.
- Significant experience with all systems engineering tasks.
- Ability to moderate requirements discussions among various departments.
- Medical device development experience is a desired.
- Knowledge of human factors and usability standards and guidelines is desired.
- Knowledge of neuromodulation systems is plus.