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We currently have a long-term contract in Andover, MA for a seasoned SQE/Project Manager with strong experience in the R&D Medical Device field ( 8-10+ years experience with Class II- III Medical devices in an R&D environment) MUST HAVE
Please email your resume to Todd.Schecter@AdeccoNA.com for review.
Responsible for managing the development & execution of Design Control deliverables, including the following:
- Review SW requirements documentation
- Develop Test Strategies, including Test Platforms & Tools
- Develop Test Plans
- Develop Test Cases
- Develop Test Procedures (i.e. Test Scripts), including critical areas such as Algorithm, White Box testing, etc.
- Manage Traceability mapping of requirements to test cases to test cases & using Caliber a plus
- Execute Test Plans & Test Scripts
- Manage Defect Reports
- Generate Test Reports
- Support Risk Management activities (Patient Safety & Security)
- Responsible for supervising SQE team
- Responsible for acting as Project Team Lead managing complex projects
- 1-2 years minimum project management experience using MS Project (MUST)
Responsible for managing issues and interfacing with cross-functional R&D departments
Experience:
- Bachelors Degree in a technology oriented discipline, Computer Science Highly Desirable
- 8 to 10 years experience in a software quality organization, Medical Device Industry
- 2-5 years Project Management experience using MS Project, including managing metrics such as Earned Value, Cost Variance, Resource Loading, etc.
- Demonstrate the ability to develop complex test platforms/harnesses to test complex algorithms, including unit & integration testing
- Familiarity with software test techniques, manual & automated, for complex Medical Devices, Class 3 or Equivalent (MUST)
- Ability to write test plans, test cases, test scripts.
- Ability to execute test plans & test scripts
- Ability to manage defects, (and using ClearQuest a plus)
- Good communication and teamwork skills
- Familiarity with Risk Based Testing methodologies
- Experience with software quality processes & SDLC methodologies in a regulated FDA environment,
- Demonstrated Knowledge of General Principles of Software Validation ins Highly Desirable.
Apply Online
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