Systems Software Compliance Engineer

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 Software Compliance Engineer to assist the R&D Software Group in adhering to our rigorous development processes.  The candidate will assist in reviewing our design documentation and functional specifications, examining the code base with the help of engineers, fill in gaps in the documentation, 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 with programming expertise, 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 reviewing code, editing and updating 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

 Position 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 development in an Object Oriented language such as Java or C#.
•    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.

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.

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