Element Science, Inc. is a medical device and digital health company focused on developing solutions at the intersection of clinical-grade wearables, machine learning algorithms, and lifesaving therapies in order to address leading causes of death and hospitalization in patients with heart disease, primarily as they transition from the hospital-to-home.
Requirements
- Experience writing and executing validation/verification plans, protocols, and software risk analysis on Medical Devices.
- Medical Device experience covering embedded software.
- Experience with scripting or programming (Python, C, or similar).
- Experience in automation frameworks.
- Experience in Threat Modeling and Software Risks.
- Working knowledge of FDA, Software Validation Guidance, 21 CFR part 820, IEC 62304, and IEC 82304-1.
- Knowledge of software quality and regulatory compliance (ISO 13485, IEC 62304) is a plus.
Responsibilities
- Author validation plans, protocols, software risk analyses for a medical device.
- Execute validation testing based on product requirements.
- Create, review and approve reports for V&V software testing and test scripts.
- Collaborate with firmware and software R&D engineers on improvements or new products.
- Lead and participate in project teams assigned to new products.
- Support and investigate customers' complaints related to product software.
- Involved in monitoring software anomalies.
Other
- Bachelor's degree in Computer Science, Software Engineering, or related field, or equivalent experience.
- A minimum of 7+ years of recent medical device experience.
- Strong cross-functional communication skills.
- Strong written skills to define and document V&V outputs.
- Excellent written and verbal communication skills.
