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Lead Software Engineer, React Native

Company: Vave Health
Location: Santa Clara
Posted on: July 31, 2022

Job Description:

COMPANY INFORMATIONVave Health is a healthcare technology startup based in Silicon Valley. Our mission is to rapidly expand access to diagnostic medical imaging, improving the quality of care for those who need it most. Vave's next-generation, handheld wireless ultrasound solution connects to the User's mobile device, enabling faster diagnosis and treatment at the point-of-care, improving patient outcomes. Vave offers a low cost ultrasound-as-a-service subscription includes ultrasound device, intuitive software, and a customizable platform addressing multiple clinical market segments.PURPOSE & DESCRIPTIONThe Lead Mechanical Engineer owns the design, development, and delivery of components, process jigs, and leads the selection of materials and MFG processes while also managing external suppliers. The position drives new product Design Verification, MFG Validation, compliance testing per Medical Device regulations, and leads failure analyses as needed. This Lead Mechanical Engineer applies a creative hands-on approach, and thrives in a fast-paced start-up environment requiring effective teamwork and self-initiative.SPECIFIC DUTIES AND RESPONSIBILITIES

  • Work with cross-functional teams to define product design specifications and develop mechanical components to meet them, applying novel and unique solutions to improve functionality such as waterproofing, latching/locking, and usability.
  • Develop test protocols, fixtures, and reports to verify designs and validate producibility.
  • Apply prototyping solutions to quickly develop proof-of-concept of designs
  • Prepare documentation in compliance with QA/RA requirements for medical devices.
  • Work with both internal MFG team and external CM's on NPI industrialization to MFG release.
  • Develop MFG assembly and test fixtures, work instructions, and assist equipment selection.
  • Drive design-for-manufacturing of tools, component assembly, and MFG workflows.
  • Responsible for on-going process/design improvements to increase yields, reduce cycle time, reduce cost-of-good, and improve product quality and reliability.
  • Identify advancements in rapid prototyping, MFG methods, materials, and related technologies
  • Lead cross-functional group in conducting analysis of NCMRs and CAPAs to determine root causes following FDA QSR and offer solutions. Document and implement improvements.
  • Partner with the QA team to drive solutions for CAPAs, SCAR's, or other quality issues.
  • Coordinate with external test labs to conduct product compliance testing per FDA & IEC regs.EDUCATION
    • BS or MS in Mechanical Engineering or related fields.EXPERIENCE & SKILLS
      • Minimum 6 years developing mechanical systems with experience developing medical devices according to FDA and IEC 60601-1 standards highly desirable.
      • Experience with relevant MFG fabrication techniques including injection molding, over-molding, machining, casting, and 3D printing.
      • Experience with polymers and metals, with knowledge of their properties and applications.
      • Experience with engineering change orders, protocols, and documentation. Familiarity with FMEA, DOE, and QSR design controls
      • Knowledge of supplier quality systems processes
      • Proven track record of new product industrialization and sustaining support with contract manufacturers. Thorough understanding of DFM.
      • Results-oriented self-starter. Ability to prioritize tasks and work independentlyVave Health is committed to equal employment opportunities. The company offers a drug-free work environment to all qualified applicants without regard to race, religion, color, sex, age, national origin, sexual orientation, disability, marital status, veteran status, or any other category protected by applicable law. Equal employment opportunity includes hiring, training, promotion, transfer, demotions, and termination.

Keywords: Vave Health, Santa Clara , Lead Software Engineer, React Native, IT / Software / Systems , Santa Clara, California

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