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Scientific. Clinical. Software Engineering

Senior Design Quality Engineer

San Jose Metro Area, CA

Job Type: Engineering Job Number: JN -032020-26595 Region: San Jose Metro Area

Job Description

  • Applies intensive and diversified knowledge of design principles, practices, and implementation in complex systems and assignments.
  • General responsibilities include, assisting with design concept generation, participating in design reviews, reviewing development protocols, and testing, to assess performance against design specification.
  • Additionally, the candidate will review reliability testing, and assist in the risk assessment of system interactions. This role will make independent decisions.
  • The ideal candidate will consult and assist in the development of manufacturing processes and procedures, ensuring appropriate design transfer.
  • Responsible for developing, implementing, and continuously improving defined processes which provide a methodical and systematic approach to ensuring that new and existing products and processes are effectively characterized and controlled prior to, and after launch.
  • Facilitates and consults for risk management policies, procedures, and practices, which consolidate regulatory and quality system requirements with business goals resulting in an effective and efficient risk management system.


  • Practices and mentors in the use of company concepts, policies and procedures, familiar with and follows standard practices.
  • Applies functional expertise routinely on the job.
  • Receives general direction and exercises considerable discretion as to work details.
  • Contributes to the definition and timely achievement of overall project goals.
  • Participates in efforts to define new components, products or processes.
  • Identifies and implements improvements to work processes.
  • Designs, plans and executes project related tasks.
  • Consults and provides training for areas of statistical quality control such as SPC, Process capability, DOE, etc.
  • Assures experimental quality through sound, independent, experimental design.
  • Participates on cross functional technical teams.
  • Provides technical direction and feedback to others.
  • Participates in project planning, process updates and contributes to experimental design.
  • Monitors work to ensure quality, and continuously promote Quality First Time.

Skills and Abilities:

  • Demonstrates success in technical proficiency, creativity, collaboration with others and independent thought. Expert knowledge of applicable regulations and standards, including FDA QSR Part 820, ISO13485
  • Expert knowledge of Quality engineering principles and concepts.
  • Experience in medical device, including software, reagents, and assay development, design control process.
  • Need software and medical device development understanding, partnered with Design Control regulations


BS in a directly related discipline. Advanced studies or training.


Typically requires a minimum of 8 years of related experience.

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