System Engineer - Software (ADX-215-20)
THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com
ArcherDX is advancing molecular diagnostics with a robust technology platform for genetic mutation detection by next-generation sequencing. By combining patented Anchored Multiplex PCR (AMP™) chemistry in an easy-to-use, lyophilized format and powerful bioinformatics software, the Archer® platform enhance genetic mutation identification. ArcherDX provides oncology-focused research products and is pursuing regulatory approval for multiple companion diagnostic assays. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn.
Our assay relies heavily on software to operate. In the Systems Engineer role your responsibility is to ensure that the software part of the assay system meets our customer’s needs and is safe and secure. You’ll do this by working cross-functionally to develop system requirements and verification and allocating those requirements to software systems. You’ll contribute to the software technical architecture and implementation as well as collaborating on verification and validation. The work you do will contribute to the overall safety and security risk management.
- Work with Agile Scrum product team.
- Work horizontally with other departments in company.
- Work vertically with customer or product owners.
- Establish and maintain compliant processes for and perform all phases of SDLC
- Configuration Management
- Contributing to system requirements and allocating them to software requirements
- Refining software requirements into software architecture using techniques of systems engineering.
- Security Risk Management
- Safety Risk Management
- Oversee software development life cycle
- Collaborate on system development life cycle
- Review, understanding, and compliance with ArcherDX HIPAA Security policies and procedures.
- Safeguarding the privacy and security of protected health information and European Union personal data.
- Processing and handling of European Union personal data only as directed by ArcherDX for purposes of personalized molecular pathology.
- 8+ years working on software engineering
- Our stack is AWS, python and CentOS, experience with these is preferred
- 4+ years working with system engineering life cycle
- 2+ years developing software architecture
- 4+ years working in pharmaceutical or medical device industries.
- Strong experience in requirements management system (DOORS, JAMA, etc.)
- Familiarity with IEC 62304/ISO 13485 preferred
- 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. You need to be able to speak up when necessary.
- Bachelor’s or Master’s in Computer Science, Software Engineering or related STEM field