29 Mar
Senior Clinical Engineering Lead (IVD)
Vacancy expired!
This Jobot Job is hosted by: Emily OlingerAre you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.Salary: $140,000 - $200,000 per year
A bit about us:We are an industry leader in computer vision and healthcare with an award winning flagship product. Our team's goal is to digitally augment clinicians with software to improve diagnostic accuracy and improve patient safety + clinical outcomes. We are looking for a Clinical Engineering Manager with experience in writing lab protocols and working in a wet lab with GLP/GCP, if this sounds like you, please keep reading and apply today! Location: San Francisco Bay area (we are a VIRTUAL company! Occasional travel to operation center is required, travel to labs/clinical trials, operating rooms, and field work is required. Level: Senior ManagerWhy join us?- Start up culture with great stock options
- 100% EMPLOYER PAID Blue Shield PPO insurance + Disability insurance
- 401k
- 5 weeks of PTO, 2 flex days, and all major holidays
- GREAT BONUS STRUCTURE
- Leadership experiene is required.
- Extensive experience writing Lab Protocols and Clinical Trial Reports for the FDA.
- Extensive experience working in a Wet Lab setting (we work with blood, viruses, human tissue, etc.) following GLP/GCP.
- Experience running a Clinical Trial with 3rd parties.
- Experience with in-vitro diagnostics.
- Must be hands on and work in the lab as needed.
- Experience with the CAPA process (Corrective Action Preventative Action) and responses to the FDA.
- Experience filing 510(k) FDA applications.
- ISO 13485 (framework we use for developing medical products).
- Background in Data Analytics or managing data in a lab setting
- Python
- Ph.D. or advanced degree
- Start up experience
Vacancy expired!