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Senior Engineer, Software – REMOTE - (JP9990)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:  Senior Engineer, Software – REMOTE - (JP9990)
Location: Thousand Oaks, CA. 91320 (REMOTE)
Employment Type:  Contract
Business Unit: GCOIS – Patient Support Programs and Mobile Applications
Duration: 8+ months (with likely extensions)
Notes:  100% REMOTE
Posting Date:  03/22/2022

3 Key Consulting is hiring a Senior Engineer, Software for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Senior Engineer will be a technical hands-on professional experienced with embedded software development in medical devices.
The Senior Engineer will be proficient in medical device development life cycle and design guidance requirements. The senior engineer will participate in software development activities including requirements, design, implementation and verification for complex electromechanical drug delivery devices.
The Device Engineering, Electrical and Software Development department leads the development of the electrical, software, and firmware subsystems of electromechanical drug delivery devices.
Key responsibilities of the Senior Engineer include:
  • Participate in defining software requirements
  • Participate in software design
  • Develop software code
  • Develop test for software unit verification
  • Develop test for software system verification
  • Perform software unit test and software verification test and generate reports
  • Perform software test tool requirement analysis, design, implementation and validation
  • Work with tools for software configuration management, software build and software verification
  • Follow a disciplined product development process and participate in technical reviews and ensure robust deliverables and documentation traceability.
  • Execute to project plans and schedules, providing high quality, on time, and on cost results.

Why is the Position Open?
Backfill.

Top Must-Have Skill Sets:
  • Strong experience with Appium on both iOS and Android, Micro Focus ALM and developing automated test execution using Unified Functional Testing (UFT).
  • Hands on experience with CI/CD pipelines, DevOps processes, Continuous Integration with Jenkins and in Version Control Systems like GitLab.
  • Prior experience with drafting test plans, test protocols, test cases, test scripts, and test scenarios as well as owning Requirements Trace Matrix (RTM) in an Agile product team.
  • Experience working with Mobile applications in a regulated environment a plus.

Day to Day Responsibilities:
In this role you will work with the Global Commercial Operations Digital Technology and Innovation (GCO DTI) Product Team that develops Mobile applications, Software-as-a-Medical-Device (SaMD), and other software products. This role works in collaboration with the Product Owner, Development Team, Digital Quality and internal IT teams.
 
  • Thorough understanding of SDLC, specifically automated QA processes in Agile development environments.
  • 3 years of experience with building Test Automation Frameworks from scratch.
  • Work closely with Product Owner, Developers and QA team members to ensure majority automated coverage and drastically reduce the scope of manual regression testing.
  • Hands on experience with CI/CD pipelines, DevOps processes, Continuous Integration with Jenkins and in Version Control Systems like GitLab
  • Strong understanding of multi-tier internet facing APIs for web and mobile applications.
  • Experience with Appium on both iOS and Android.
  • Proficiency in writing native app code tests using Swift XCTest and Espresso.
  • Experience with Micro Focus ALM and developing automated test execution using Unified Functional Testing (UFT).
  • Strong understanding of cloud technologies, such as, AWS, Azure.
  • Experience in developing documentation and training around automation processes, newly implemented technologies, and strategies in the Agile product delivery model.
  • Follow Amgen’s governance processes, procedures, specifications, design controls, and applicable compliance standards and guidance documents.
  • Strong prioritization skills and ability to quickly pivot in a dynamic environment, manage test automation for multiple releases with high degree of quality built-in.
  • Prior experience with drafting test plans, test protocols, test cases, test scripts, and test scenarios as well as owning Requirements Trace Matrix (RTM) in an Agile product team.
  • Be a leader for change and process improvements.
  • Possess excellent oral and written communication skills with the ability to effectively communicate with peers, external partners, and executive management.
  • Hands-on experience with Agile: Scrum, SAFe.
  • Expert in PowerPoint, Excel, Jira, Confluence, Test tool (ALM, Digital.ai), Firefox, GitLab, Jenkins.
  • Experience working with Mobile applications in a regulated environment a plus

Basic Qualifications:
Doctorate Degree
OR
Master's Degree and 3 years of Engineering experience
OR
Bachelor's Degree and 5 years of Engineering experience
OR
Associate's degree and10 years of Engineering experience
OR
High school diploma/GED and 12 years of Engineering experience

Preferred Qualifications:
  • 5+ years of experience in software/firmware development.
  • Experience in Medical Device development life cycle and knowledge of design control.
  • Experience with formal testing and generating test protocol & reports
  • Extensive experience in microcontroller-based hardware and software designs, familiarity with various microcontroller architectures
  • Familiarity with lab instruments such as oscilloscope, logic analyzer, and simulators.
  • Strong problem solving, risk assessment, and risk management skills.
  • Familiar with the following standards: Quality System Regulation – 21CFR820, Quality Management – ISO 13485, Risk Management – ISO 14971, EU Medical Device requirements – Council Directive, 93/42/EEC, Medical Electrical Equipment – EN 6060, Medical Device Software Standard – IEC 62304, ISO 11608 Needle-based injection system for medical use
  • Proficiency in C programming language
  • Knowledge of STM8 microcontroller, gitlab, jenkins, ALM, and doors

Red Flags:
  • Less than 2yrs of experience with automation testing.
  • No prior experience working in Agile product teams.
  • Engineering degree, computer engineering
  • Software engineer with automation testing, is the ideal candidate

Interview process:
Phone screening followed by in-person interview.



We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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