Onsite Design Quality Engineer, Software

Posted 2 weeks ago

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About the role

  • Design Quality Engineer responsible for comprehensive software quality documentation and compliance with regulatory standards at Philips. Leading assessments and validations of software design inputs for quality assurance.

Responsibilities

  • Facilitates the development, maintenance, and management of comprehensive software quality documentation
  • Leads the assessment of software designs, including reviewing test and performance data
  • Conducts in-depth root cause analysis for software quality issues
  • Validates key software design inputs such as usability, reliability, performance, localizability, safety, privacy, and cost
  • Provides effective oversight of the execution of software quality plans and associated risk management activities

Requirements

  • Bachelor's / Master's Degree in Computer Science or equivalent
  • 3+ years of experience with Bachelor's in areas such as Software Quality Engineering, Design Quality Management, CAPA Methodologies, Product Quality
  • Experience in applying 21 CFR 820, ISO 13485, IEC 14971 and IEC 62304
  • Working knowledge with IEC 60601 and other relevant medical device standards
  • Must be able to successfully perform minimum Physical, Cognitive and Environmental job requirements with or without accommodation

Benefits

  • Generous PTO
  • 401k (up to 7% match)
  • HSA (with company contribution)
  • Stock purchase plan
  • Education reimbursement

Job title

Design Quality Engineer, Software

Job type

Experience level

Mid levelSenior

Salary

$115,000 - $143,500 per year

Degree requirement

Bachelor's Degree

Location requirements

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