Program Manager
Avani Tech Solutions Private LimitedHighlight
Summary
About the Role
About You
- Bachelor’s degree in Engineering (Biomedical, Electrical, Mechanical, or related), Life Sciences, or equivalent.
- 8+ years in program/project management roles leading cross-functional teams.
- 5+ years of experience in medical device product development.
- Proven track record of successfully delivering medical device programs from concept to market launch (including regulatory clearance/approval).
- Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 14971 risk management, IEC 62304 (software), and global regulatory pathways (510(k), De Novo, PMA, MDR).
- Proficiency with project management tools (e.g., MS Project, Jira, Smartsheet, or similar) and standard office software.
- Excellent leadership, communication, and stakeholder management skills; ability to influence without direct authority.
Avani Tech (FlatMind) was founded in 2011 on three core principles; Technology, Innovation, and Partnership. We believe in these core principles that drive business value, constant innovation, and a sense of trust in partnership. We are in the constant process of shaping our organization to address the change in market demands that changes our client needs. We believe in focusing on core competencies that enables us to create niche, quality of services and long lasting business relationships. Our focused areas are in SAP, Microsoft .NET/SharePoint, Web Commerce, Database Management, Software Testing, and Project Management consulting. We deliver our services based on project or based on T&M depending on our client needs. In this process, we also advise our customers the best possible approach in delivering a solution or service; our approach is always a win-win strategy. FlatMind management team brings over 20 years of cumulative experience in managing large scale IT engagements in US. We value our client business needs and make every attempt to improve our customer´s efficiency, productivity and optimal usage of IT budgets.