Duties and Responsibilities:
1. Design,
Implementation and Maintenance of test
and validation plans, procedures and
equipment
2. Automation
of test execution using scripts, tools
and software
3. Test
Plan, test case, test result
documentation
4. Plan,
co-ordinate and oversight of product
verification efforts from start to
finish
Desired Training and Experience Required
(Training and Experience Commensurate
with Position Level:
5. Proficiency
in developing test software and test
scripts
6. Knowledge
of systems development and validations
methodologies (V model,
OO development, Iterative development)
7. Knowledge
of test lifecycles (unit, subsystem,
system, integration and regression)
8. Knowledge
of test tools, test management tools and
software (Ethereal,
Winrunner, Test Director)
9. Knowledge
of requirements and tracking tools
(Requisite Pro, DOORS, DDTS, Clarify)
10. Experience
in writing System,/Software Assurance
plans, test plans, test
procedures and test cases.
11. C
/C++, Perl, Python programming
experience
12. Good
communication skills, both verbal and
written
13. Excellent
conceptual, analytical and
problem-solving ability
14. Knowledge
of FDA 510(k) approval process and GMP
requirements
15. Knowledge
of device communications protocols, IP
networking (TCP/IP, IP Network
config), Wireless local area network
standards (802.11x)
16. Knowledge
of Enterprise security standards
17. Experience
with servers (Windows and UNIX variants
based),
Hand
held devices
and Windows based desktop systems and
embedded systems
18. Experience
in the medical device industry,
preferably in physiological monitoring