Overview
On Site
Hybrid
Accepts corp to corp applications
Contract - C2H
75% Travel
Skills
DOCUMENTATION
METRICS
medical device
MENTORING
BioMedical
Continuous Improvement
System Level
Strategic Direction
ADME
Clinical Diagnostics
Assay Development
Design Control
Test Engineering
System Verification
Job Details
Associate Director of Software Test Engineering
Location: Hercules, California, United States ( Hybrid / 3 days a week from office).
6-9 Months contract to Hire.
Job Description:
We are seeking to fill a key leadership role for Associate Director, Software Test Engineering. Your typical day includes driving the strategic direction of the software test engineering team, collaborating with cross-functional system verification and validation groups, reviewing design control documentation, overseeing automation testing frameworks, developing organizational KPIs, and mentoring test leads to ensure the successful delivery of medical device software and clinical assays to market.
- Lead the Software Test Engineering team for clinical diagnostics, focusing on medical device software and assay development.
- Develop and implement robust test strategies, automation frameworks, and ensure end-to-end verification and validation excellence.
- Collaborate closely with the System Verification and Validation team to ensure comprehensive system-level testing.
- Drive organizational development through the use of health metrics, dashboards, and continuous improvement initiatives.
- Support sustaining programs for legacy products in the field, ensuring compliance and quality continuity.
- Education: Bachelor's or Master's Degree in Computer Science, Engineering, Biomedical Engineering, or a related technical discipline.
- Work Experience: 15+ years of progressive experience in software / Director/system test engineering roles, with at least 5 years in leadership roles.
- Deep experience in automation development, system verification/validation, and medical device regulations.
- Background in clinical diagnostics or in vitro diagnostic devices (IVD) strongly preferred.
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