Lead Engineer at Makani Science
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
- 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
- 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.