Lead Software Engineer, React Native
Company: Vave Health
Location: Santa Clara
Posted on: July 31, 2022
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
- 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
- Prepare documentation in compliance with QA/RA requirements for
- 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
- 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
- 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
- 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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