We have an outstanding Contract position for a Software Quality Assurance Engineerto join a leading Company located in theValencia, CAsurrounding area.
The Software Quality Assurance Engineer III will serve as a Quality representative in the Neuromodulation Software/Firmware product development . The Software Quality Assurance Engineer III will provide Quality Engineering input throughout the product life cycle process. The Software Quality Assurance Engineer III will be actively participating in design activities of new product development and sustaining activities for commercialized product . The Software Quality Assurance Engineer III will be involved in the development, testing and validation of Software/Firmware products. In the Neuromodulation division, we continue to advance science in electronic implantable technologies that help patients manage debilitating chronic pain and neurological conditions such as movement disorders.
Actively working within a team of Product Software Quality Assurance Engineers
Actively contributing to all aspects of Software/Firmware Quality Assurance activities in a highly regulated Active Implantable Medical Device environment
Ensures the quality of software systems, validate product software and firmware requirements, security requirements and compliances
Oversee design, development, and test of software related to all product lines during their entire development life cycle, from requirements gathering phase to the retirement phase
Creation and execution of Design Validation Plan, Protocols and Reports to perform System level testing of Neuromodulation products and report any issues discovered
Perform review of design, development, and testing of software and firmware used in product lines
Perform review and approval of documentation associated with user requirements, hazard analysis, security risk assessment, usability, functional and design specifications, design reviews, test protocols, requirements traceability, etc.
Actively working to support Automated Test Equipment validation activities
Validation activities, which encompass reviews of User Needs Requirements, Design Requirements, Functional, Architectural, Module Design Details, Code and Design reviews, Unit tests, Integration tests, System level (black box), Structural (white box), Test Automation, Ad-Hoc/Exploratory test activities, Cybersecurity, Usability, and Risk Management, Design FMEAs, and Hazard Analysis
Basic Hiring Criteria:
Bachelor's degree in Computer Science or Software/Electrical Engineering
5-8 years with BS degree, 3-6 years with MS degree, 0-3 years with PhD
Minimum of 3 years of Software testing in commercial products
Working knowledge of testing processes and methodologies
Manual testing and documentation experience in a regulated environment
Understanding of Software Development Life Cycle Processes per IEC 62304
Some experience in Programming Languages such as C#, C++, Swift, Node.js, Java/JavaScript, Cloud, Windows, iOS, Android, Python, LabView
Desired Qualifications:
Master's degree in Computer Science or Software/Electrical Engineering
Must possess excellent organizational, clear verbal and written communication skills
Must be team-oriented with people skills and positive can-do attitude in dealing with a large number of customers, and several competing tasks from various departments (R&D, Marketing, Manufacturing, Quality and Regulatory, Clinical, Project Management, etc.)
Must be detail-oriented and have a passion for ' Build Quality In ' the products
Experience working in the medical device industry or other highly regulated environment
Basic academic knowledge of principles of Neuromodulation
Experience with CAPA, Complaint Handling and External Audit
Experience/Understanding of Risk Management as per ISO 14971
Understand Premarket Cybersecurity Guidance, Post Market Cybersecurity Guidance and 81001-5-1
Understand Bluetooth technology
Understand Mobile applications development
Understand aspects of HIPAA and GDPR compliance practices
ASQ Certified Quality Engineer (CQE) or ASQ Certified Software Quality Engineer (CSQE)
Benefits offered to vary by the contract. Depending on your temporary assignment, benefits may include direct deposit, free career counseling services, 401(k), select paid holidays, short-term disability insurance, skills training, employee referral bonus, affordable medical coverage plan, and DailyPay (in some locations). For a full description of benefits available to you, be sure to talk with your recruiter.
VEVRAA Federal Contractor / Request Priority Protected Veteran Referrals / Equal Opportunity Employer / Veterans / Disabled
The Company will consider qualified applicants with arrest and conviction records.
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