Location: San Jose,CA, USA
W2 Only, no C2C or 3rd party candidates
*Potential for conversion to perm depending on performance*
SENIOR R&D ENGINEER & R&D ENGINEER
SUMMARY:
Sr. R&D Engineer needed to provide support and guidance for medical device design and development activities for a thriving medical device organization.
DUTIES & RESPONSIBILITIES:
* Provide input, guidance and support for product concept and design, development, prototyping, manufacturing and testing
* Supplier management related to materials and components, quality inspection and resolution, etc.
* Design and execution of relevant tests such as Design Verification and Validation, DOEs, animal/bench testing, Test Method Validation, Process Validation and relevant data collection, analysis, reporting and documentation
* System Integration, Design Control, Engineering Analysis, Coordinating of Usability/Human Factors and Clinical testing, and additional development activities
* Regulatory, Quality Systems, and ISO Compliance
* May provide mentorship, training, supervisory and/or leadership support
* Other duties, as required
QUALIFICATIONS & REQUIREMENTS:
* 8+ years of relevant R&D engineering experience, including extensive medical device (catheter-based preferred) research and development demonstrating good understanding of related regulatory, Quality Systems and ISO compliance
* Proven software proficiency in MS Office, MS Project, Visio, Minitab and using SolidWorks to generate models and drawings for components and fixtures, reflecting a solid understanding of molding and machining tolerances
* Good understanding of Design Control processes and compliance and Risk Management including FMEAs, hazard analysis, harms list, etc.
* Experience with Design for Manufacturing/Assembly (DFM/DFA) and Design for Six Sigma tools, controls and processes
* Experience with developing and executing Design V&V, DOEs, bench tests, Test Method Validation, and Process Validation
* Metrology tools experience for advanced measurements
* Project Management skills, including ability to support Gantt chart development
* Relevant BS Degree
LOCATION:
Work will be performed onsite in the greater San Francisco Bay Area.