Description
OverviewWith a systems focus, this position is responsible for ultimate system reliability, driving reliability strategies into to the subsytems, and ensuring that the interfaces between subsystems are correctly designed. This requires understanding system design and development, overall system behavior, and subsystem interactions and tradeoffs.
With a firmware emphasis, this position is also responsible for the reliability of the embedded subsystem. This requires a deep understanding of embedded software (firmware) design and analysis; firmware development, simulation and test; and firmware-hardware-system interactions and tradeoffs.
Position Responsibilities
* Understand therapy (clinical) performance, product function(s), and product use environments to appropriately and strategically apply technical knowledge, reliability tools and reliability methodologies to drive reliability improvements.
* Think about proving and demonstrating reliability from the beginning, and drive the identification and proper collection of performance objectives, design requirements, measures and metrics.
* Identify product/system use conditions and quantify how they impact performance
* Perform systematic reliability analysis against features, requirements, architecture, interfaces, and designs, through the appropriate application of reliability engineering techniques (e.g. fault tree analysis, failure trending and analysis, reliability forecasting, etc.) to understand product and process robustness.
* Plan and execute the required activities and prepare the associated document deliverables for assigned projects, such as:
Analyze legacy product performance data to provide reliability design input
* Conduct reliability analyses (e.g, FTA, FMEA, DOE, etc.) against the features, requirements and design. Perform reliability statistical analysis and projections.
* Understand use conditions and help establish or review specs/requirements for components, subassemblies, products and processes to assure adequacy and testability of requirements relative to those use conditions.
* Prepare meaningful test plans as required. Direct execution, review results, conduct statistical data analysis, and write test reports. Assure resolution of issues raised during testing. Testing may include characterization, evaluation against specification requirements, and testing for reliability using a risk-driven strategy utilizing expertise on physics of failure, stress identification and analysis of design margin/capability.
* Support design verification, process qualification, product performance, manufacturing process performance and component vendor performance. Review proposed process and design change requests for potential impact on product reliability and testing needs required to support the change.
* Prepare data summary reports and other reliability inputs to Regulatory Affairs for submission to regulatory agencies to support market release product review and approval.
* Effectively transfer responsibilities and product performance expectations to post market reliability engineering in conjunction with Market Release.
* Assure compliance to organizational procedures, regulatory requirements and industry standards, and timely completion of assigned CAPAs and audit findings.
Basic Qualifications
BS Engineering & 9 years experience
OR
Master's Degree & 7 years experience
Experience working with and/or leading multi-disciplinary product development teams.
Background in comprehensive product design and development (requirements analysis, concept development, subsystem and component design, systems integration, verification/validation, and operations and product support)
Desired/Preferred Qualifications
* 2 years Reliability Engineering experience
* Experience in medical devices or other highly regulated industry, preferably implantable medical devices
* Knowledge of DFSS, DFLS or DRM, and robust design practices
CRE, or equivalent certification
* Knowledge of reliability tools and practices that effectively support requirements, design, integration and verification, and validation
* Experience in high-criticality ultra-low power systems.
* Experience working across geographies and cultures
* Experience leading organizational change
* Proven ability to extensively apply and teach system engineering and firmware engineering principles in the design of highly reliable, complex systems
* Understanding of reliability engineering principles, with ability to apply them
* Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience)
To find out more about Real please visit www.realstaffing.com