ROLES & RESPONSIBILITIES:

An experienced, dynamic and self-motivated individual, required to test state-of-the-art mass spectrometry software products. Successful candidate will be a motivated self-starter with strong leadership, organizational and communication skills.

  • Participate in all phases of product development from product definition to final release
  • Work closely with multiple teams to ensure successful integration of platform and product SW packages across a variety of environments and topologies
  • Coordinate and perform end-to-end testing of Chromatography and Mass Spectrometry software solutions
  • Act as the quality gatekeeper for large-scale SW programs involving multiple components delivered from globally distributed development teams
  • Communicate project status and issues to other functional teams, stakeholders, and management
  • Facilitate the removal of conflicts and roadblocks as they arise to ensure team efficiency
  • Generate clear documentation for project documents and status reports
  • Create and execute integration, compatibility, and solution-level test cases
  • Participate in project planning and progress tracking
  • Contribute to the delivery of the CMD software projects on time and within budget

REQUIRED SKILLS:

  • BS in Chemistry, Biomedical Engineering, Biochemistry or equivalent, MS in Chemistry or related discipline
  • Minimum 8 years of laboratory experience or testing scientific software or experience with Liquid Chromatography/Mass Spectrometry applications.
  • Experience with Medical Device and/or Regulatory device background a plus
  • Familiarity with ISO 13485 & 21 CFR 820 Compliance is desirable

Knowledge, Skills, Abilities

Required:

  • Excellent leadership and communication skills
  • Ability to test and investigate and solve problems involving multiple component
  • Motivated, Driven, Autonomous work competency
  • Decision making for quality results
  • Provide technical direction and feedback
  • Ability to work in a team
  • A thorough understanding of qualitative and quantitative analytical chemistry
  • Understanding and ability to apply statistical mathematics
  • Demonstrated experience and knowledge of software test methodologies
  • Demonstrated technical\\scientific knowledge in Life Sciences using Mass Spectrometry or similar techniques
  • Familiarity with the entire software development process, particularly in an Agile environment
  • Demonstrated experience in using test management tools
  • Experience with defect-tracking systems

Preferred:

  • Familiarity with Quality System Regulation and FDA expectations for software and hardware validation is a plus

Job Overview

  • Date Posted: October 18, 2022
  • Location: San Jose, CA.
  • Job Title: Product Evaluation Scientist

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