| Job Description | Summary
The ION Torrent within Life Technologies is in need of a Sr. Director of diagnostic product development, to lead a diagnostic product development and test effort. The position is within Ion Torrent’s product development group, and the individual is responsible for overseeing several technical functional deliverables on ION Torrent’s next generation sequencing platform: hardware, software, sensor, analytical assay development and system verification and validation. The individual is also responsible for managing system level documentation work per FDA’s QSR guidelines. A successful candidate will be a key member of a program core team to work closely with cross functional representatives to effectively drive the overall key technical milestones during the product development life cycle. This full-time position is based in our South San Francisco office.
Key Responsibilities
· Is responsible for the technical functional deliverables, from product designs, product development to product testing, which encompasses analytical assays, an instrument platform, software and a semiconductor sensor
· Owns the overall product development plan and consolidated system test plan; and is responsible for updating and maintaining the plans
· Is responsible for setting and owning the system level performance specifications, to ensure that the specifications are traceable and meet the product requirements
· Is responsible for owning technical reviews and reporting development and test results to a cross functional team and to a project governing body
· Is responsible for product transfer from Research and Development to Manufacturing; such as establish SOPs, QC test methods, metrics and specifications
· Is responsible for establish system test protocols for external test sites
Requirements
Ph.D. (or an equivalent advance degree) in molecular biology, chemistry, or related scientific disciplines
Familiar with next generation sequencing platforms and technologies
10+ years of experience in diagnostic assay and system development and commercialization; with a track record of developing and commercializing FDA-cleared, CE marked regulated product(s) in recent years; preferably worked on a FDA 510(k) class II product development and commercialization
Solid understanding on FDA’s Quality System Regulation (QSR) and ISO 13485 requirements; and a good understanding of design control (assay development, instrument development and SW development); and has a thorough understanding and practiced good traceability matrix; practiced phase gate product development process in meeting FDA’s QSR
Must have demonstrated strong leadership and organization skills in leading a cross functional teams in product development
Must be a highly motivated individual, must have great amount of enthusiasm for working in a fast paced environment, must have a can-do attitude
Excellent verbal and written communication skills
Superb organizational skills and detail oriented working style |
| | Company | | Life Technologies Corporation | Job Code | | State or Province | | California | | |
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