Job Description
The Systems Engineer translating the products user needs into system requirements, define system architecture and complete systems analysis (design tradeoffs, throughput and product risk).
Systems engineers along with other discipline engineers develop the instrument and various module designs, test and refine the designs and verify them to the requirements before release to production.
The System Engineer helps to ensure that the regulatory requirements are satisfied, address the product and technical risks as they arise throughout the program.
The Systems Engineer maintains close interaction with product owners to ensure we are delivering the product that meet the customer’s needs.
Responsibilities
- Lead effort to create system level concepts & analysis for new project proposals. Review and critique concepts created by proposal team.
- Ability to prepare Systems Engineering cost and schedule estimates on major design development efforts. Provide technical presentation support and consultation to Business Development Team for proposals and during development.
- Plan and lead engineering testing to evaluate operating characteristics of products or processes. Translate test data into design requirements and criteria.
- Work with the various engineering disciplines to develop the instrument or module design will meet the system / module requirements
- Lead Technical Design Reviews at various stage of development to insure the conceptual / detailed approach and the various supporting analysis will lead to a design that meets requirements.
- Contribute to System Integration, and lead Design Verification by defining, specifying and supervising testing, analysis and integration activities.
Ensure reports are prepared to document the results of such activities.
- Support the design review and phase gate process to ensure that engineering deliverables are at the appropriate level to meet FDA / ISO requirements & standards.
- Accountable to oversee the development of requirements for different disciplines such as Software, Electrical, Mechanical, Electro-optics and others.
Qualifications
- Bachelor’s Degree in Engineering
- 9 years of complex electro-mechanical instrument systems engineering experience
- Hardware / software integration experience.
- Must be available for daily onsite presence
Preferred Requirements :
- Master’s degree in Engineering.
- Medical Device experience
- Extensive development experience in at least one or more of the following engineering disciplines is required : software, mechanical, electrical, optics, fluidics and should possess knowledge of advanced theories, concepts, principles, and processes.
- Ability to provide technical leadership as required during the investigation of complex medical instrumentation products.
Accountable to oversee the development of requirements for different disciplines such as Software, Electrical, Mechanical, Electro-optics and others.
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