Test Engineer I/II/III - Medical Device Software (ADX-183-20) at ArcherDX
ArcherDX, Inc., creates catalog and custom next-generation sequencing (NGS) assays that are purpose-built to identify mutations and gene fusions from clinical sample types. By combining novel enrichment chemistry, automated informatics and a user-friendly workflow, Archer™ products remove the bottlenecks associated with using next-gen sequencing in a translational setting.
The qualified candidate will work as part of software team and is responsible for testing cloud-based medical software against test plans, requirements, specifications and test cases. The tester will work closely with members of the engineering team to identify software anomalies and issues with the system. This candidate is also responsible for maintaining and updating test documentation.
Job performance will involve a variety of activities including:
- Write, maintain, update and execute manual test cases based on software requirements and specifications
- Setup test environment and prepare test data
- Perform functional testing against the test plan and software requirements
- Defects logging, tracking and maintaining
- Troubleshoot software anomalies
- Generate test report and results analysis
- Evaluate verification and validation standards and protocols
- Develop technical documents (test plans, requirements, protocols, report etc.) to comply with regulatory requirements
- Assist in development and maintenance of standard procedures for design control, change management, risk management, test method validation, process validation and related areas of the quality management system
- 1+ years of experience in software testing (required)
- Experience with medical software Validation and Verification testing (big plus!)
- O Or Experience working in another regulated environment may be considered (aerospace, automotive, etc.)
- Experience with Microsoft Word and Excel (required)
- Experience with Mac OS
- Experience with github, confluence is a plus
- Experience working with distributed systems and/or cloud environments is a plus.
- Experience of different testing strategies and methodologies
- Thorough understanding of FDA Quality System regulations in relation to computer system validation is a plus
- Familiar with critical elements of the design history file including risk management, design verification and validation tests and ensuring compliance of these elements to procedural requirements is a big plus
- You have strong communication and presentation skills
- You want to work on a team. You want to work closely with smart, passionate engineers and scientists. You want to get regular feedback.
- You are able to communicate complex issues with respect and tact.
- You are comfortable working in a regulated environment.
- We have high standards
- Details matter
- We have a lot of rules
- Integrity of character. Your work is a final gate to the release of a medical device, you need the integrity to speak up when things are not right.
- CS major preferred, other engineering, science and mathematics backgrounds may be suitable
· The candidate can work onsite in ArcherDX’s office located at Boulder area or be field based.