Software Product Manager (Hyb & Seq)

Organization
NanoString Technologies
Job Location
530 Fairview Ave N
Seattle, WA 98109
Salary
Competitive
Benefits

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.
Job Description

Nanostring is seeking an experienced software (SW) product manager/business analyst to join the Research & Development group.  The Diagnostics Sequencing SW Product Manager will be responsible for all aspects of the software requirements for our Hyb & SeqTM instrument, a novel single-molecule hybridization-based next generation sequencing (NGS) technology. 

In this position you will collaborate with marketing, software, hardware engineers and designers to lead projects through discovery, prototyping, presentation, requirements writing and translation of details to the development team.  Experience with NGS and IVD diagnostic products is strongly preferred. Medical device experience is required.

You will own the success of delivering against project goals.  To be successful, you are creative, collaborative, process-friendly, and have the ability to work simultaneously towards both short- and long-term project goals. Join our team and help us unlock the power of the genome!

Essential Functions:

  • Responsible for overall specification of software requirements for a novel diagnostic instrument and software platform for sequencing, including both on instrument workflow and downstream analysis
  • Identify, select and manage outside SW solutions firms to bridge product development and commercialization needs with required expertise
  • Own creation and iteration of general product requirements and detailed software specifications
  • Work collaboratively with R&D product team, software team, regulatory, quality, and marketing stakeholders to understand short-term and long-term objectives for the product
  • Serve as a liaison between Marketing and Development in identifying priorities for key software features, conducting hazard analyses, and developing software feature roadmap for the product
  • Establish detailed SW, hazard/risk, and human factors documentation compatible with regulatory requirements for Class II and/or Class III medical products
  • Create wireframes, write detailed user requirements, and own overall product usability and feature set
  • Document and communicate software requirements to ensure that they are complete, consistent, concise, comprehensible, traceable, feasible, unambiguous, verifiable, and that they conform to standards
  • Be actively engaged with the design teams and assist project team members in requirements refinement during the product development life cycle
  • Proactively monitor product/market trends of implementing cutting-edge software solutions/architectures
Requirements

Qualifications and Requirements (Education, Experience, Specific Skills):

  • Three or more years of experience in requirements analysis and specification
  • Experience in NGS is required
  • Experience with IVD or other medical products (preferably diagnostic products) is required
  • Experience driving the development of software from concept phase through validation
  • Prior exposure to molecular biology, bioinformatics, and/or sequence technology is preferred
  • Solid understanding of all phases of the software product development lifecycle
  • Experience interviewing both technical and non-technical users and stakeholders to gather requirements and facilitate the identification and finalization of design decisions
  • Excellent verbal and written communication skills. Excellent presentation skills.
  • Demonstrable experience designing product workflows based on user/stakeholder research.
  • Skilled at documenting design goals and requirements for instrument and software workflow, as well as user requirements
  • Working knowledge of medical device requirements including: Quality System Regulation (21 CFR 820), IEC 62366, ISO 13485, ISO 14971
  • Experience and understanding of IEC 62366/HE75 standard requirements. Applicable in-practice experience of utilizing IEC 62366 standard requirements as part of product design
  • Experience in conducting hazard and/or risk analysis related to software features
  • Ability to work both independently and closely in collaboration with a core product team
  • Ability to present to various groups including project team leads and the executive team
  • A Bachelor's degree in a biology-related field OR a computer science-related field is required.
About Our Organization

NanoString Technologies is a publicly held provider of life science tools for translational research and molecular diagnostics. The company's technology enables a wide variety of basic research, translational medicine and in vitro diagnostics applications.

NanoString's products are based on a novel digital molecular barcoding technology invented at the Institute for Systems Biology (ISB) in Seattle under direction of Dr. Leroy Hood. The company was founded in 2003 with an exclusive license to develop and market the technology. In 2008, NanoString launched its first commercial instrument system and began international sales operations with its first multiplexed assays for gene expression analysis. In 2010, the company launched new applications for the system to support microRNA analysis and copy number variation detection, and in 2013 launched Prosigna®, its first in vitro diagnostic product for prognosis of early stage breast cancer.

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