This is a backfill Position IVD Project Manager Duration :6 months+ contract no guarantee to go direct Location: remote to start and eventually on site Benicia, CA Immigration Status : Citizen, GC, H4 EAD, EAD, OPT, CPT Qalification: BS DEGREE / MS Preferred PMP Cert a nice plus 10+ years Experience level: Minimum 10 years. We can look at the resume if someone is close enough (e.g. 8 years) Is 13485 experience a must have? yes They will be a cross functional lead. This is a very visible role with the potential for a contract to hire I do not want someone just with IT experience. Exp apply Design Control principals Project Management lead for launching SARS-CoV-2 (510k) and supporting Clinical Immunology IVDR project. Must have some exp working for a Diagnostics company ( IVD ) Strong PM experience w/ background & Knowledge of FDA/QSR and ISO 13485 What you'll be doing: (Please state job responsibilities, duties, etc.) A cross-functional leadership role that acts as the 'General Manager' of the core team. Accountable for all the aspects of the program. The primary responsibility of the Program Manager is to lead product development projects. The successful candidate will be able to partner with their project teams to move products to market as quickly as possible while maintaining high standards of quality. Scientific background (preferably in diagnostics) and excellent communication skills (written and verbal) are mandatory. Creation, implementation and execution of project plans/timelines to achieve business goals Creating and maintaining project records including project and design history files Identifying potential project risk and guiding teams around potential obstacles Managing critical path items and successfully removing team roadblocks Leveraging well developed interpersonal skills to build & maintain positive working relationships with functional groups throughout the organization