Sr. R&D Systems Engineer - Santa Rosa
|Nombre del Puesto:||Sr. R&D Systems Engineer|
|Fecha de Publicación:||17/07/2017|
This engineering position requires high level technical and leadership skills to advance the development of an innovative product to treat pathologies of the aorta. We are looking for individuals who have a background in systems engineering and are passionate about system maturity/reliability, integration, characterization, verification, and validation. The ideal candidate would be someone with relevant educational and/or demonstrated experience improving complex systems with interacting mechanical components. The engineer will apply technical principles, theories, and new concepts to collaboratively solve difficult technical problems. The engineer will work under the general direction of the project lead but will have latitude in determining methods of solving problems, design and construction of prototypes, and creation of test methods with associated product testing. The engineer will participate in cross-functional and cross-site development teams that are responsible for different aspects of the project such as implant development and pre-clinical evaluations.
Sr. Level Systems Engineering Aspects
Work with peer systems engineer(s) during development of user needs & intended uses and design input requirements to ensure they are validate-able and verifiable respectively.
Develops approach & authors Verification & Validation Plan, documenting scope of system V&V effort, while working with product/functional engineers to ensure proper and complete coverage.
Authors Integration Plan and corresponding test protocols during design development phase of project to progressively and predictably build design maturity. Executes tests per defined Integration Plan.
Works with various stakeholders to understand scope of characterization needed, including need to understand design capability. Executes system characterization efforts.
Influence product/component integration and characterization plans in order to assist in incremental system maturity. Works with engineers cross-functionally (different departments) to achieve results.
Authors design verification and design validation protocols and reports. Executes system verification and validation activities.
Works with Human Factors engineer to ensure inclusion, tracing and proper coverage of applicable user needs in their summative usability study.
Works with Clinical to ensure inclusion, tracing and proper coverage of applicable intended uses in their pre-clinical or clinical study.
Plan and execute Test Method and Non-product validations (spreadsheet, software, etc.), and equipment and tooling qualification, per project needs.
Monitors progress of assigned tasks to defined project schedule.
Produce high quality deliverables while complying with relevant SOP.
Authors Summary report and other relevant inputs for submission by Regulatory Affairs to regulatory agencies in support of market release review and approval.
General Sr. Level Engineering Aspects
Join a team of engineers and technicians in the design and development of innovative implants and delivery systems
Apply advanced problem solving skills, critical thinking, technical principles, and theories to solve complex problems
Generate mechanical designs using SolidWorks and work with a variety of vendors to rapidly prototype new concepts for testing and evaluation
Build catheter delivery systems capable of delivering a mitral valve implant to a high degree of precision
Conduct testing using DOE methodology and other experimental design tools, evaluate results using appropriate statistical analysis tools, and generate test reports
Provide engineering and technical support to pre-clinical evaluations
Design and develop new test methods and equipment
Work with internal and external advisors/leaders to determine product requirements
Create manufacturing processes, write process instructions, and train operators
Work under direction of project lead toward pre-determined long range goals and objectives
Act as advisor and mentor to other engineers and technicians
Bachelor's degree in engineering (Mechanical, Materials, or Biomedical) - Advanced technical degree is preferred
4+ years of experience in medical device product development or 2 years of experience with MS degree
High level proficiency of technical principles, theories, and design concepts in the field of medical
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|Sr. R&D Systems Engineer|