Description
As a Principal Engineer, this position is expected to serve as both a technical leader and a change agent. As such, this Engineer is expected to: apply extensive technical knowledge and principles in field of practice, have broad knowledge of other related/interfacial fields of practice, and generally be recognized as a subject matter expert; develop technical solutions to complex technical problems that require regular use of ingenuity and creativity; guide the successful completion of major projects/programs, often in a project leadership role; influence the organizational strategy and objectives; represent the organization as a prime technical contact for reliability and other technical projects and/or programs; and interact with senior external personnel on significant technical matters often requiring coordination between organizations.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. Implement to meet these criteria in collaboration with Design Engineering, Manufacturing Engineering, Regulatory Affairs, Quality, and other cross-functional partners.
* Proactively design in reliability and demonstrate that products/systems perform as expected in all use environments throughout their intended life (minimize the need to iteratively redesign for reliability):
- 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:
Define project reliability objectives and associated- metrics
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.
Basic Qualifications
BS Engineering & 9 years experience
OR
Master's Degree & 7 years experience
OR
PhD & 4 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)
* 2 years Reliability Engineering experience
* Experience in medical devices or other highly regulated industry, preferably implantable medical devices
* Exposure to or experience working in or with Design, Quality and Operations
* Knowledge of DFSS, DFLS or DRM, and robust design practices
CRE, or equivalent certification
* Demonstrated ability to apply knowledge to drive reliability
* Knowledge of reliability tools and practices that effectively support requirements, design, integration and verification, and validation
To find out more about Real please visit www.realstaffing.com