Lead Engineer

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