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.
• 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