Software Quality Engineer III

POSITION: Software Quality Engineer III

FULLTIME/PARTTIME: Fulltime

LOCATION: Valencia, CA Hybrid (expectation to be on-site 3 days a week)

This position is anticipated to be up to 12 months in duration

SCHEDULE: 08:00:AM - 04:30:PM M -F

PAY RANGE: $59.44 - 62.93 hourly
(Exact compensation may vary based on skills, experience, and location. Base pay information is based on market location.)

JOB DESCRIPTION:

• 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.

JOB RESPONSIBILITIES:

• 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 Neuromodulation 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.

REQUIRED QUALIFICATIONS:

• BS 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 process 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

Preferred qualifications:

• MS 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 (RD, Marketing, Manufacturing, Quality and Regulatory, Clinical, Project Management, etc.)

• Must be detail oriented and have a passion to 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)

WORKING CONDITIONS:

• May on occasion be exposed to loud sounds and distracting noise levels, such as from office equipment.

• The ability to lift up to 30lbs

• Use of computers and technology

Here at Canon Recruiting, People are our priority, and we are committed to Include Diversity in every segment of who we are. It is only through our Diversity, we are made a stronger organization, and increase our ability to provide top tier candidates that our clients have come to know Canon for. We have an inclusive environment all employees are celebrated for their unique differences. The different perspectives and experiences of our workforce give us the competitive advantage that is essential for success in an ever-changing market. By promoting inclusion with the same enthusiasm, we devote to quality and competency, and using the experience from a diverse assortment of backgrounds and experiences, Canon is able to improve the services and value we deliver to clients, employees, and customers. At Canon, Diversification and Inclusiveness are much more than a corporate ambition; they are a critical component in our daily corporate life.

Canon Recruiting is committed to a diverse and inclusive workplace. Canon Recruiting is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.

The pay range for this position is listed above. Base pay information is based on market location.
We will consider for employment qualified applicants with arrest and conviction records. Our range of benefits may include health care and 401(k) savings plans.
For individuals with disabilities who would like to request an accommodation, please email