Test Manager
Your Tasks & Responsibilities:
- Define, Execute & Continuously improve Verification & Validation Strategy in alignment with Business goals and product roadmap.
- Develop & maintain test governance, quality metrics and release readiness assessment.
- Lead the System test team and drive a proactive culture focused on defect prevention, accountability and continuous improvement.
- Drive adoption of CI/CD quality gates and Shift-Left testing practices.
- Partner closely with Product Management, Clinical Experts, System Engineers, Architects, Quality/Regulatory to ensure comprehensive validation of product functionality and clinical workflows.
- Drive incorporation of customer feedback, field issues and post-market learnings into validation activities.
- Represent Test function in program status meetings and in leadership forums, providing clear communication of quality status, risks, mitigation plans and release assessment.
- Establish quality metrics and dashboards for management reporting
Qualification And Experience:
Education & Experience
- Bachelor’s degree in computer science, Information Technology, or a related field,
- 10+ years of Software Development/Testing experience.
- 5+ years of leadership experience managing test teams in a regulated environment.
- Experience with medical device software development & validation.
- Experience leading validation activities for enterprise-scale healthcare products.
- Experience supporting regulatory audits and submissions.
Technical Skills
- Test Strategy development
- Risk-Based Testing & Medical device software validation techniques.
- NFR & Cybersecurity testing.
- Working knowledge of Medical Device standards (DICOM, HL7) & Regulations (IEC 62304, ISO 14971, ISO 13485, FDA 21 CFR Part 820)
Soft Skills & Problem-Solving
- Strong strategic thinking, planning, and organizational skills
- Stakeholder Management & Influencing skills
- Data driven decision making
- Conflict resolution
- Cross-Functional Collaboration
- Effective communication and interpersonal skills