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Job Opening :: Sr. Software Quality Engineer :: Los Angeles, CA (Hybrid) at Remote, Remote, USA
Email: [email protected]
Hello,

I hope youre doing Great..!

My name is Ben (Technical Recruiter) and I am from Talent Junction LLC. I am reaching out to you about an exciting job opportunity with one of our clients. Talent Junction LLC is a highly recognized provider of professional IT Consulting Services across the USA.

Should you have interest, please send a Microsoft word copy of your resume to [email protected] Please include the job title, authorization to work, interview/project availability, and contact information along with the details requested below. Remember, if you have the right set of aptitude and attitude, we have just the right job for youplease rush your resume now, we can guarantee immediate interviews.

Job Title: 
Sr. Software Quality Engineer with Medical Device Experience

Type: Contract

Location: 

Los Angeles, CA (Hybrid)

JOB DESCRIPTION:

The Senior Software Quality Assurance Engineer will serve as a Quality representative in the medical device (Neuromodulation) Software/Firmware product development. The Senior Software Quality Assurance Engineer will provide Quality Engineering input throughout the product life cycle process. The Senior Software Quality Assurance Engineer will be actively participating in design activities of new product development and sustaining activities for commercialized product. The Senior Software Quality Assurance Engineer 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 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 
medical device 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.

Actively working on Software related 
CAPA.

 
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.

Minimum of 
(4-8 years) of Software testing in commercial products

Working knowledge of testing process and methodologies

Experience working in the 
medical device industry or other highly 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

Understand Bluetooth technology

Understand Mobile applications development 

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

Strong written and verbal communication, judgment, decision-making, and critical thinking skills

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 to Build Quality In the products

Understand aspects of HIPAA and GDPR compliance practices

ASQ Certified Quality Engineer (CQE) or ASQ Certified Software Quality Engineer (CSQE)

Ability to work independently and as a part of a team in fast-paced environment.

Ben K

Technical Recruiter 

Talent Junction 2060 Walsh Avenue, Suite 122, Santa Clara, CA 95050

Direct : 14083337913 
Ext - 103 | E-mail Id : ben
@talent-junction.com

Hangout: | ben
@talent-junction.com |

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Job Opening :: Sr. Software Quality Engineer :: Los Angeles, CA (Hybrid)
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Fri May 31 01:09:00 UTC 2024

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Location: Los Angeles, California