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Senior Software Quality Engineer

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Portal Instruments

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Location:
United States , Cambridge

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Category:
IT - Software Development

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Contract Type:
Not provided

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Salary:

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Job Description:

The Software Quality Engineer will contribute to software development for Portal Instruments’ software-controlled drug delivery system. You will lead software design verification/validation testing activities from requirements and testing implementation through closure of documentation.

Job Responsibility:

  • Drive Portal’s software V&V efforts throughout the development lifecycle:generate and maintain requirements, implement and execute tests, maintain documentation packages
  • Work cross-functionally with the V&V team and Software engineering team to outline software and firmware requirements and ensure compliance to applicable standards
  • Assess and maintain test coverage and acceptance criteria using a risk-based approach in accordance with ISO 14971 and IEC 62304
  • Develop and review front-end software tests and tools for use in validation of software requirements
  • Ensure software verification activities are documented in accordance with Portal's quality management system
  • Manage qualification and validation of software packages used by Portal
  • Support electrical and mechanical compliance testing through the development of software driven test harnesses
  • Lead the software risk management process using FMEA and other risk management techniques
  • Evaluate system performance by designing, executing, and documenting verification and validation plans

Requirements:

  • Minimum 3 years of experience in developing medical device software requirements and tests for software validation
  • Experience with Software Automation – can read and understand scripting and programs written using Bash and/or Python
  • Foundation in computer science principles including familiarity with data structures, algorithms, and software design
  • Familiarity with SW development in languages including C and C++11. Experience in languages like Python is preferred
  • Experience working with embedded devices, preferably in a medical device environment
  • Ability to multitask and manage competing priorities
  • Strong oral and written communication skills
What we offer:
  • Stock options
  • Roth and traditional 401(k) retirement plans
  • Health and dental plans
  • PPO and HMO healthcare plans
  • Dental, orthodontic, vision and accident insurance plans
  • Paid family medical leave
  • Short- and long-term disability
  • AD&D insurance
  • Flexible spending accounts (FSA)
  • 20 days of vacation
  • 13 company-wide state and federal holidays
  • Company-wide holiday shutdown
  • Sick days
  • Employee assistance program
  • Commuter reimbursement account
  • Dependent care accounts
  • On-site parking
  • Bike room and locker room with a shower
  • Professional development opportunities
  • Southern New Hampshire University discount program
  • Daily lunch
  • Casual dress code
  • Pop-up wellness benefits
  • Happy hour
  • Annual company sponsored events
  • Volunteer opportunities
  • Annual donation match program

Additional Information:

Job Posted:
December 11, 2025

Employment Type:
Fulltime
Work Type:
Hybrid work
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