Chelmsford, United States
about 2 years ago
Principal Design Quality Assurance Engineer
This position reports to the Manager, Design Quality Assurance (DQA) and provides technical leadership and technical oversight to the validation test development and execution work in R&D. The Principal DQA Engineer will also be a hands-on participant in his/her assigned product development projects meaning he/she will also conduct functional testing as needed.
As an integral development team member, the Principal DQA Engineer will be an active participant in, and in some cases lead Test Plan reviews with others in R&D. He/she will provide test recommendations to others in DQA and to the development team as needed, especially to other members of the DQA group. The Principal DQA Engineer will also be an active participant in product and subsystem requirements development ensuring that all product requirements are testable and meet clinical needs
- Lead project validation test efforts
- Implement, review and create validation/verification test cases and test plans
- Apply risk management principles to guide test plan development.
- Research and review test equipment specifications to create and refine test cases as needed.
- Develop and review automated test protocols where appropriate.
- Perform all testing as assigned
- Identify, report, and follow up on test failures and observed defects
- Work with the product development teams to isolate failure modes and capture methods to reproduce product problems
- Review and create new/enhanced product requirements to ensure that the products are testable and meet both written and implied requirements
- Mentor less experienced DQA Engineers as needed to teach them how the products work and the proper way to test them
- Detailed understanding of the underlying biomedical principles and clinical applications of the products under test and appreciation for the end user clinical needs and practices
- Nurse, Paramedic or other similar experience a plus
- Clear and complete understanding of effective software test design especially as it relates to system level testing of embedded systems
- Sound knowledge of all relevant Medical Device industry standards
- Demonstrated accomplishments in the development of software and hardware testing processes and programs
- Proficient with MS/Office, demonstrated ability to learn and use software engineering tools and applications in MS Windows and Linux environments.
- Excellent written, verbal and interpersonal skills
Required/ Preferred Education and Experience:
- BS, Software Engineering, Electrical Engineering, Biomedical Engineering or equivalent, advanced degree preferred.
- 10+ years experience testing software in a product development environment, at least 5 years testing in the medical device industry