Description:

About the role:

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.

This is a hybrid position based out of Valencia CA with the expectation to be on-site 3 days a week. d

Your responsibilities will include:

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 Boston Scientific Neuromodulation 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 Boston Scientific 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

Skills:

software quality, python, software quality assurance, labview

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.