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Project Manager II/Senior

Job Summary:

NanoString Technologies is seeking an energetic, outgoing, and detailed-oriented Project Manager to join our team.  This position will have a leading role in managing the development of a new instrument platform including instrumentation, consumables, and reagents for Hyb & SeqTM, a novel single-molecule hybridization-based next generation sequencing (NGS) technology. Responsibilities include managing internal and external development teams including design firms, OEM / contract manufacturing vendors, and reagent process development and design transfer from Concept Phase through Commercialization Phase, according to our ISO 13485 compliant design & development lifecycle.  Scope includes high complexity, multidiscipline, large-size projects.  This mid to senior-level Project Manager will work across R&D, Quality, Regulatory, Manufacturing, Supply Chain, and external subject matter experts.

Essential Functions:

  • Manage and track contract deliverables, milestones, and change control with external vendors
  • Develop work breakdown structure, timelines, integration points, and track progress metrics
  • Define and drive execution of development iteration 'sprints' and facilitate design reviews
  • Manage execution and track progress of key performance metrics for internal process and product development activities including stability, yield, and COGS
  • Contribute to vendor evaluation and sourcing strategy selections
  • Establish and maintain components of the product's Design History File (DHF)
  • Budget generation, tracking, reconciliation, and reporting
  • Communicate and formally present project status to senior management

Requirements (Education, Experience, Specific Skills):

  • Experience managing medical device instrumentation (Class II/III), IVD, or GMP reagent chemistry development, process development, design transfer, and manufacturing projects highly desired
  • Direct experience managing external vendors and global development teams
  • Experienced in Risk Management and knowledge in BS EN ISO 14971:2012 preferred
  • Comfortable working within electronic quality management systems (e.g. MasterControl, Agile)
  • Minimum of 5 year working directly as a Project or Program Manager
  • BS degree or higher in a technical discipline required; engineering preferred, MBA a plus
  • PMP certification or University Project Management certificate highly desired

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.
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