Indotronix Avani Group

Compensation

Full Description

The Software Staff Program Manager will be a pivotal contributor in advancing the strategic initiatives within the software business segment of the Transplant Diagnostics division. This role involves leading programs that support our internal software tool development programs, as well as the development of Research Use Only (RUO) and In Vitro Diagnostic (IVD) software products and platforms. To be successful, this high-visibility position demands effective leadership over multiple tasks and teams, requiring a candidate with a collaborative approach, focus on deliverables, and excellent interpersonal skills. Moreover, this role requires a blend of proficiency in software development, program management best practices, and the ability to cultivate strong industry relationships with colleagues and customers. Key Responsibilities • Lead cross-functional core teams and conduct regular project meetings, supervise assigned deliverables, develop timelines, and build presentations for senior leadership at critical phase gates. • Guide the development, verification, validation, and release of RUO and IVD software applications, aligning them with product and market needs, regulatory guidelines, and customer requirements. • Identify potential risks and issues, along with developing effective mitigation strategies. Proactively address challenges to maintain compliance, product quality, and project execution. • Continuously define and optimize software project management and development processes, methodologies, and tools to improve efficiency and effectiveness. • Maintain clear communication lines with all team members, providing regular updates on project status and achievements, and resolving barriers to execution to ensure projects are completed on time according to quality standards and within the applicable scope and budget. Education and Experience • Bachelor’s degree in Computer Science, Math, Science, or a related technical field. Advanced degree in business or technical/scientific field preferred. • Minimum 4 years demonstrated experience leading software product development projects in an ISO 13485 regulated environment using traditional project management methodologies (e.g., phase gate processes, waterfall, etc.). • PMP certification a plus. Knowledge, Skills and Abilities • Proven ability to influence and drive accountability across a matrixed organization. • Outstanding written and verbal communication skills: assertively and effectively articulates sophisticated concepts and ideas to broad audiences. • Familiar with Medical Device Manufacturing and Design Controls for the development of medical devices (e.g., 21CFR820, ISO 13485). • Experience with waterfall and scaled agile framework and/or quarterly planning processes in software development. • Experience with JIRA, Confluence, and other collaborative productivity tools • Self-managing and self-motivating, capable of prioritizing tasks effectively to meet timelines and expectations. Is curious, inquisitive, innovative, and never satisfied with the status quo. Possesses a proactive, helpful, ‘can-do’ attitude. Comments for Suppliers: Looking for someone with all or some of the following: Subscription software platforms and lifecycle management Experience with LIMS and laboratory workflows Cloud-based SaaS program leadership and delivery Enterprise software integration and compliance focus Program management across regulated software environment