VP of Product Development at Mammoth Biosciences
San Francisco, CA, US
The VP of Product Development will be expected to drive the product development activities around the design and development of Mammoth’s IVD products. This position is responsible for managing the product development staff while also serving as the lead in interfacing between Mammoth and its external design and development partners.  This person will work closely with other functional areas to translate customer requirements into appropriate product requirements and development plans; oversee development of the product and/or system (hardware, software, assay and consumable, as applicable); coordinate projects in their scope, schedule, resources and budget; establish Design Control adherence during development; lead system integration activities; support the validation activities and eventual launch of the IVD platform to the clinical market and/or direct to consumer market (OTC). Fluency with hardware/software, consumable and assay development life cycles, creating design inputs and outputs, design verification and design validation with regard to IVD product development is required.  Strong technical knowledge and hands-on experience with the tools and methods used in system development and assay development are essential, particularly within point-of-care molecular diagnostics, point of care, microfluidics, fluorescence, optoelectronics, systems engineering and manufacturing. 

RESPONSIBILITIES

    • Lead all product development aspects of Mammoth’s IVD portfolio.
    • Work with engineering and scientific staff (internally and externally) to complete all system development activities towards the launch of the product (ultimately and effectively transferring the product from development to manufacturing).
    • Hire and coach in-house team members to form a strong and cohesive unit.
    • Oversee and manage the technical relationship with external partners tasked to successfully design and implement the product system as specified and budgeted.
    • Work with the Marketing team to gather, organize, and prioritize customer/market needs that become requirements for the system.
    • Plan and coordinate the creation of comprehensive hardware/software requirements, assay requirements and functional specifications that feed into the design and development of the system. 
    • Proactively identify potential risks/issues and work with the team to develop mitigation strategies. 
    • Plan and coordinate the execution of appropriate design verification/validation testing.
    • Work with Operations in the scale up of materials and processes for all system components’ production firstly to clinical study levels then to commercial manufacturing volumes (with external partners as appropriate).
    • Play a strong supporting role in development and maintenance of Quality System elements, specifically for Design Control.

REQUIREMENTS

    • Graduate degree (PhD) in Engineering/Science, or related field
    • Minimum of 8-10 years professional experience in developing IVD systems following applicable regulatory guidelines
    • Experience with complete and successful launches of new IVD product systems 
    • Exposure to Experience with clinical laboratory and direct to consumer products strongly desired
    • “Been there, done that” experience for IVD product development from early stage development (innovation stage) to late stage development (product validation) required 

SUMMARY OF BENEFITS

    • Competitive salary and equity
    • Full health/vision/dental benefits
    • Unlimited vacation
    • Free breakfast/lunch/dinner/barista
    • Free gym
    • Public transportation commuter subsidy
    • 401(k) matching
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