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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
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