Sign upLog in
Engineering Jobs

Staff R&D Engineer

SoloPoint Solutions, Inc.

  • Pleasanton, CA
  • 6 days ago

    Highlights

    Manage suppliers and coordinate external sterilization, packaging, and biocompatibility testing; communicate progress, results, and risks to stakeholders . Responsibilities Lead design and development of new single-use devices and accessories, serving as technical lead and, when needed, core team lead .

    Numbers & Facts

    LocationPleasanton, CA

    Description

    Qualifications
    • Bachelor's in Mechanical Engineering, Biomedical Engineering, or a related field with 10+ years of medical device experience, or an advanced degree with 9+ years
    • Proven track record taking designs from concept through commercialization, applying DFX principles to scale
    • Design expertise in two or more of: injection molding, electromechanical sub-systems, catheter construction, endoscope construction, fluidics
    • Proficiency in SolidWorks, design for manufacturability, tolerance stack analysis, and GD&T
    • Experience with design of experiments (DOEs) and statistical data analysis; simulation experience (CFD, FEA) a plus
    • Working knowledge of ISO 13485 and FDA 21 CFR Part 820, plus sterilization and biocompatibility testing in a regulated industry
    • Experience leading technical teams and mentoring engineers
    • Strong collaboration, communication, and hands-on problem-solving skills; must comply with applicable vaccination requirements
    Responsibilities
    • Lead design and development of new single-use devices and accessories, serving as technical lead and, when needed, core team lead
    • Keep all design work compliant with design controls, partnering cross-functionally to ensure manufacturability, reliability, and scalability
    • Build prototypes, design fixtures, run feasibility studies, and execute testing to guide product decisions
    • Solve engineering problems through root cause analysis and data-driven methods
    • Define and lead qualification strategies for new designs and processes, aligning with teams across the organization
    • Translate customer needs into product requirements and engineering specifications
    • Develop test methods, write and execute protocols, and author reports and risk documentation
    • Manage suppliers and coordinate external sterilization, packaging, and biocompatibility testing; communicate progress, results, and risks to stakeholders

    Similar Job Searches

    Systems Engineer Jobs in Pleasanton, CADesign Engineer Jobs in Pleasanton, CAProduct Engineer Jobs in Pleasanton, CATooling Engineer Jobs in Pleasanton, CAApplications Engineer Jobs in Pleasanton, CAApplication Engineer Jobs in Pleasanton, CAResearch Engineer Jobs in Livermore, CAResearch Engineer Jobs in Milpitas, CAResearch Engineer Jobs in Fremont, CAResearch Engineer Jobs in Santa Clara, CA

    Similar Jobs

    See more jobs