Nanōmix is growing rapidly and needs talented, energetic people to join us in Emeryville, California - located between the San Francisco Bay Bridge and Berkeley. High performance and innovative thinking drives Nanōmix success as a pacesetter in the fields of nanotechnology and point-of-care diagnostics. We offer a competitive compensation package including stock options, excellent benefits, and significant opportunities in a high energy start-up environment.
Nanomix is the leader in the development of mobile, affordable point-of-care diagnostics, offering a handheld testing platform, the Nanomix eLab, and assays that provide rapid, accurate, quantitative information for use in settings where time-to-diagnosis is critical for clinical decision-making and improved patient care. Our goal is to expand access to quality healthcare by bringing diagnostics to the point of initial patient interaction, whether in the hospital or in pre-hospital, remote, or alternative settings.
We are currently looking for a strong, experienced leader to manage and drive our product development activities. The position reports to the Executive Office and includes tactical management of product development and registration activities as well as input and participation in the eLab platform development strategy. Specifically, we seek to hire an experienced IVD product development leader to accelerate our platform programs, define the assay menu for the platform, and lead the development and regulatory approvals of additional IVD assays. This is an opportunity to lead a world class team to deliver an advanced, mobile medical diagnostic platform of urgent need to the healthcare industry.
Nanomix has a strong team-oriented culture and a history of innovation. As a developing company, the cultural fit of the individual we hire is very important.
About You
Experienced IVD product development background Product development team management and leadership experience Good working knowledge of IVD development including clinical, V&V, and approval processes Creative, flexible and inclusive leader Enjoy working in a collaborative, cross-disciplinary team environment Located in the San Francisco Bay Area
Principal Duties & Responsibilities
The successful candidate will have significant IVD product development industry experience and will apply scientific, technical, and product development expertise in all phases of developing and obtaining regulatory approval for diagnostic assay products. Own the product development activities of the company including project plans, budgets, resource requirements, technical approaches, and timelines for product development programs. Work under the Quality System. As a key member of Management, coordinate plans, projects and activities with the other functional groups in the company including engineering, production, commercial, and finance. Team with the commercial leadership to understand market needs and integrate them into the product development programs and product menu strategy. Provide technical and management support to the Assay Development team in all phases of the development process including developing and writing/review of protocols, reports, proposals, invention disclosure, patent applications and scientific papers. Responsible to establish assay performance characteristics and design & perform verification and validation studies to support regulatory submissions. Participate in process development, QC development, and manufacturing transfer to support IVD products.
Requirements
6-10+ years of experience in developing and obtaining approval for IVD diagnostic assays. Experience with FDA and CE processes. 3+ years of management experience Working knowledge of Design Control, Quality Systems Management, ISO 13485, and cGMP. Experience with Point of Care products and markets is preferred.