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Sr R&D Engineer - Medical Device (W2 Only)

Redbock - an NES Fircroft company
San Jose, CA Full Time
POSTED ON 1/14/2025
AVAILABLE BEFORE 4/7/2025

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.

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