Requirements Traceability Analyst, Systems Engineering

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

Are you interested in being part of an organization that operates at the cutting edge of life-sciences?  Do you want to work in an environment of diverse technologies from robotics through nanotechnology, optics and high-performance computing systems?
 

Pacific Biosciences is seeking a Requirements Traceability Analyst/Compliance Engineer to ensure our systems are designed, built and tested to the highest quality.  The candidate will work closely with product marketing, scientists, hardware, software and systems engineers, as well as test groups, to manage requirements and traceability. The candidate will analyze our design, development & test processes and generate reports to demonstrate compliance with regulatory systems. 
This position demands someone who is technically sharp, capable of working in a very diverse set of disciplines and is very detail oriented.

 Responsibilities:         

•    Review product and design input requirements for adequacy and resolve ambiguous, redundant
or unverifiable requirements.
•    Review Verification and Validation Test Plans
•    Establish and ensure end-to-end traceability from product requirements through functional specifications and test case results
•    Generate traceability, risk management, usability and essential requirements reports as required
•    Develop tools as need to support traceability, analyses and reports
•    Review work products generated by design teams for compliance to the requirements
•    Manage process and work instruction documentation and change-orders
•    Manage documentation to generate and maintain a complete Design History File
•    Successfully work within a challenging and extremely multi-disciplinary environment

Requirements

•    Bachelor’s or Master’s engineering degree
•    At least eight years’ experience in Systems Engineering or related field
•    Experience with requirements management, risk management and traceability systems such as HPQC/ALM or DOORs
•    Experience with regulatory processes and procedures, including: ISO 13485, ISO 14971, IEC 62304, IEC 62366 and 21 CFR Part 820
•    Working knowledge of other engineering disciplines and work practices including, optical, mechanical, hardware and software and associated test practices
•    In depth exposure to any of the following areas and disciplines highly desired: error budgeting, statistical analysis, optics, chemistry, biochemistry, bioinformatics, molecular biology
•    Ability to write complex systems requirements
•    Familiarity with configuration control, requirements tracking systems, and technical documentation
•    Experience with Agile and document control processes
•    Knowledge of certification test processes
•    Candidate should have experience in working within a multi-disciplinary team in a fast-paced, technically challenging environment
•    Strong and effective inter-personal and communication skills

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.

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. 

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