Systems Analyst/Technical Writer

Organization
Pacific Biosciences
Job Location
1380 Willow Road
Menlo Park, CA 94025
Job Description

Are you interested in working for an organization operating on the bleeding edge of the biotech sciences?  Do you have a desire to be part of a company creating cutting edge technology that is uncovering the mysteries of life itself?  Do you want to work at a company that uses robots and lasers and nanotechnology as well as high performance heterogeneous computing systems to see a single DNA molecule sequence in real-time?  Pacific Biosciences is seeking a Systems Analyst/Technical Writer/Compliance Engineer to assist the R&D Software Group in adhering to our rigorous development processes.  The candidate will assist in the writing and editing of our design documentation and functional specifications as well as creating traceability links between requirements, specifications, and test references in our HPQC database.  The candidate will work closely with our software, hardware, and systems engineers to understand the technical details of our instrument and data processing pipeline to enable clear documentation creation and requirements tracking for adherence with our best practices policies and for regulatory compliance purposes.  This is a position that requires someone who is technically sharp, very detail oriented and capable of learning about cross functional concepts and can understand the relationships between specific technical requirements and their effects on each other.

 Responsibilities:         
•    Work in an exciting multi-disciplinary organization of software and hardware engineers, bioinformaticians, chemists, and molecular biologists developing state-of-the-art, single-molecule, genomic analysis systems.
•    Assist software engineers in the writing and editing of design and functional specification documents as well as assist in writing automated test design documents.
•    Maintaining documents including bringing all documents to a high and consistent level of quality.  This effort also includes dealing with different document formats and the use of multiple editing tools.
•    Establish data record linkages in our HPQC database between product requirements, functional specification items, and automated test references to create regulatory compliant traceable matrices.
•    Maintain requirements traceability integrity throughout project execution including verification and validation phases.
•    Guarantee that all of the documentation produced by our software engineers is meeting our regulatory compliance requirements including adhering to our standardized formats.

Requirements

•    M.S. in computer science, electrical engineering or in physical science disciplines; candidates with a similar B.S. degree and a high level of relevant experience will also be considered.
•    At least 4 years of experience in creating and maintaining a traceability database for product requirements, functional specification items and test references. 
•    At least 4 years of experience in Technical Writing of Functional Specifications and Design Documents for highly complex multi-disciplinary systems.
•    A person, who is technically sharp, very detailed oriented, and naturally curious in a diversity of disciplines with an emphasis in software engineering.
•    A person with an excellent command of verbal and written English as this role requires significant documentation expertise.
•    A person who is good at creating clear, descriptive, block diagrams using tools such as Visio as well as having an ability to adopt to different document editing tools to accommodate original authors’ preferences.
•    An understanding of FDA and other compliance regulations such as 21 CFR 11, IEC 62304, IEC 62366, ISO 13485, and ISO 14971.
•    Preference is shown to candidates with strong analytical and technical writing skills who have experience working with diverse personalities across multiple disciplines.

About Our Organization

Pacific Biosciences’ mission is to transform the way humankind acquires, processes and interprets data from living systems through the design, development and commercialization of innovative tools for biological research. The company has developed a novel approach to studying the synthesis and regulation of DNA, RNA and protein. Combining recent advances in nanofabrication, biochemistry, molecular biology, surface chemistry and optics, Pacific Biosciences has created a powerful technology platform called single molecule, real-time, or SMRT™, technology. SMRT technology enables real-time analysis of biomolecules with single molecule resolution, which has the potential to transform the understanding of biological systems by providing a window into these systems that has not previously been open for scientific study. 

A research duo finds that science and technology graduate students who turn away from academic careers do so because of changes in their own interests.

Students whose classmates are interested in science are more likely to think about a career in science, technology, engineering, and mathematics, a new study says.

CNBC reports that the genetic counseling field is expected to grow as personalized medicine becomes more common.

Gladys Kong writes at Fortune that her STEM background has helped her as a CEO.