Makani Science

Reinventing respiration monitoring

Lead Engineer at Makani Science

Location
Irvine, California / Remote
Job Type
Full-time
Experience
6+ years
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Michael Chu
Michael Chu
Founder

About the role

Makani Science is a medical device startup looking for an experienced, hands-on individual to help lead the engineering and R&D efforts. We are looking for someone to help grow the company with a small team of like-minded colleagues and to eventually transition into the VP of R&D role as the company scales

Minimum qualifications:

  • BS or MS in electrical or biomedical engineering, or other relevant engineering fields.
  • Extensive experience in Diagnostic Medical Device development in a QMS environment.
  • Proven track record of multiple cycles going through the FDA 510(k) product development and clearance process.

Desirable experience and skills:

  • Experience with wearable monitors
  • Basic understanding of data processing and algorithms (including machine learning)
  • Team player that enjoys working with other functional personnel to develop products and bring them to market in a timely manner *Ability to create budgets and set timelines for engineering staff *Have management experience to guide the engineering team

Tasks:

  • Report to CEO/Founder
  • Participate in weekly team meetings
  • Maintain and refine Product and Software Requirements
  • Lead outsourced product development
  • Lead production prototype manufacturing with outsourced Partner
  • Lead product test, validation, and verification process
  • Provide test results and additional technical documentation for FDA submission (510(k)), working with outsourced Regulatory Affairs
  • Provide technical input to tasks pertaining to product development, customer usage, and commercialization (e.g., Contribute to Product User Manual)
  • Lead engineering and product development for future product definition and specification
  • Work with the management team to develop and maintain timelines and budgets
  • Work with the management team to develop supplier and partner agreements for outsourced technical and manufacturing needs

Why you should join Makani Science

Makani Science is a medical device startup looking to reinvent respiratory monitoring. We're a small close-knit team looking to take our novel respiratory monitor through FDA clearance and to product launch.