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The job search that fits your personality
Personalized matches for clinicians, for the coolest jobs in the clinic or beyond

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The job search that fits your personality
Personalized matches for clinicians, for the coolest jobs in the clinic or beyond
We are looking for a Senior Quality Engineer (Software Design Controls) who will be involved in quality management system (QMS) and software development life cycle (SDLC) activities, in accordance with FDA’s Quality System Regulation (QSR), ISO 13485, and other applicable regulatory requirements, as well as best practices in the software industry. This position is within the Tempus Quality Assurance (QA) group.
Responsibilities
● Support Tempus’ SDLC activities for medical device software and Software as a Medical Device (SaMD).
● Support Tempus’ QMS activities by maintaining relevant procedures, identifying improvement opportunities, and providing training
● Ensure required documentation and DHF deliverables are generated and maintained throughout SDLC of medical device software/SaMD, including SRS, SAD, SDS, V&V, traceability, risk management/FMEA, and cybersecurity.
● Apply innovative, scalable and risk-based approaches to meeting compliance for novel technologies in a fast-paced, multi-project environment.
● Maintain knowledge of the evolving regulatory landscape for Digital Health, Artificial Intelligence and Machine Learning technologies, and incorporate best practices in Tempus’ SDLC processes and QMS.
● Support compliance to various QMS procedures and activities including ...
The Real Dill ☘️
Drug development is hard - Big Pharma wouldn't be a $1 TRILLION+ industry if it wasn't. From end to end development, some estimates show nearly a decade of work and $1B of investment is needed to bring a single drug to market, not to mention the incredible attrition rate of molecules that don't pass muster to progress from preclinical to Phase 1/2/3 clinical trials and regulatory approval. Three of the biggest challenges facing the drug development industry in increasing the success rate of bringing drugs to market are the focus of Tempus Labs: drug discovery (finding new molecules to develop), clinical trials (verifying the usage and viability of turning molecules into medicines) and diagnostics (finding the right patients to take each highly complex, specialized drug being developed). It makes sense that these processes could be opportunities for artificial intelligence to accelerate the process - helping doctors understand disease progression by finding the right patients for a trial, etc. Startups in this space are raising ludicrous amounts of money (Tempus Labs itself has raised over $1B) which is a startling contrast to the adjacent digital health space where companies are striving for overall valuations in the $1B ballpark...it's a different game, with different players, and, in some ways, even more competitive. (September 2023)
Jon Lee, PT, DPT, OCS, FAAOMPT, MBA
Pickle co-founder
Advancing precision medicine through the practical application of artificial intelligence in healthcare.
MissionFor each patient to benefit from the treatment of others who came before by providing the healthcare industry tools that learn as we gather more data.
Wow FactorClaims >90% of the top 20 Pharma companies partner with Tempus
Pickle is not affiliated with listed companies unless otherwise noted.