Nemedio is hiring an entry to mid level Software Validation Engineer who has successfully assisted in the validation of Quality Management Systems and other regulated software in the Medical Device and/or Pharmaceutical industries to join our growing team.
JOB RESPONSIBILITIES:
- Develop an in-depth understanding of Nemedio's philosophy, products, and services
- Author and execute Test Cases and Test Protocols and Test Reports
- Perform validation activities, including, but not limited to, executing tests/protocols
- Perform testing/debugging of software items/modules, not limited to including initiating any associated bug reports and other required documentation in the tracking system as required
KEY QUALIFICATIONS:
- 1-5 years experience with software validation in a FDA regulated environment
- Knowledge of User Requirements and Software Requirements
- Have written validation protocols and reports
- Passion for Nemedio's mission, the medical device industry, and bringing medical devices to market faster
YOU HAVE WORKING KNOWLEDGE WITH:
- 21 CFR Part 820 / ISO 13485
- 21 CFR Part 11
- Non-Product Software Verification and Validation
- GAMP5
- ISO 14971
- Agile software development
BENEFITS:
- Competitive compensation package with stock options
- Self directed PTO with Paid Holidays and Sick Days
- Health, dental, vision, and life insurance
- Flexible spending account (FSA)
- Commuter benefits for parking & transit
- Budget to attend conferences, train, and further your education
- Relocation assistance
ABOUT NEMEDIO
Backed by a team of seasoned medical device experts, Nemedio radically de-risks and simplifies the development process for medical devices. We provide the framework, process, tools, knowledge, and connections to go from prototype to market for traditional, high-tech, and robotic medical devices.