Director Program Management - Software

Veranex’s mission as an Innovation CRO is to improve patient outcomes by accelerating our clients’ innovations to market.  As the world’s only end-to-end professional services firm focused on MedTech, we take clients’ Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting. 

About This Role 

Veranex has an exciting opportunity to join our team as a Director of Program Management - Software. As a member of the Program Management organization at Veranex, you will help improve lives globally through medical technology innovation by leading the successful execution of software development programs for medical device and digital health clients. 

The successful candidate will bring deep expertise in software program management, medical device product development, and consulting services. This individual will serve as a strategic partner to clients and internal teams, ensuring complex software projects are delivered on time, within budget, and in compliance with quality and regulatory requirements. 

The ideal candidate has 12+ years of experience leading software development programs, with demonstrated success managing cross-functional teams in regulated environments, including medical devices, Software as a Medical Device (SaMD), digital health solutions, connected devices, and embedded software systems. 

What You Will Do 

The Director of Program Management - Software is responsible for overseeing a portfolio of software and software-enabled medical device development programs. This role provides leadership across multiple client engagements, establishes effective delivery strategies, monitors program health, and ensures successful execution against contractual, technical, quality, and financial objectives. 

The Director serves as the primary escalation point for complex delivery challenges, drives operational excellence across programs, and partners closely with engineering, quality, regulatory, and business development teams to deliver exceptional outcomes for clients. 

Responsibilities 

Client & Program Leadership 

• Serve as the executive-level program lead for strategic software development engagements. 

• Build and maintain trusted client relationships, ensuring high levels of satisfaction and long-term partnership growth. 

• Lead program planning, governance, and execution activities across multiple concurrent projects. 

• Ensure software development programs are delivered on schedule, within budget, and aligned to client requirements and quality expectations. 

• Establish program success metrics and drive accountability across cross-functional teams. 

• Identify, communicate, and mitigate program risks, dependencies, and resource constraints. 

• Provide proactive issue resolution and executive-level decision support throughout project lifecycles. 

• Manage overall program financial performance, including forecasting, revenue recognition support, profitability, and resource utilization. 

Software Development Program Oversight 

• Lead execution of software programs spanning embedded software, application software, cloud-connected systems, mobile applications, cybersecurity initiatives, and Software as a Medical Device (SaMD). 

• Ensure alignment with software development lifecycle (SDLC) best practices, Agile methodologies, and applicable quality management processes. 

• Partner with Software Engineering leadership to establish delivery plans, release strategies, and development roadmaps. 

• Monitor program performance through dashboards, KPIs, resource forecasts, and portfolio reviews. 

• Guide teams through technical, operational, and regulatory challenges associated with software-based medical products. 

• Support Design Control activities throughout the software development lifecycle, including requirements management, verification, validation, traceability, and risk management. 

Portfolio Management 

• Provide portfolio oversight for multiple client engagements and software development programs. 

• Collaborate with executive leadership to establish portfolio priorities and resource allocation strategies. 

• Track and report program status, financial performance, delivery metrics, risks, and key business indicators. 

• Ensure effective utilization of software engineering resources across projects. 

• Drive continuous improvement initiatives that enhance delivery quality, operational efficiency, and client outcomes. 

• Implement and promote best practices in program management, Agile delivery, and software quality assurance. 

Business Development & Consulting 

• Partner with Business Development teams to support proposal development, client presentations, and solution strategy discussions. 

• Contribute to project scoping, statement of work (SOW) development, budget creation, effort estimation, and resource planning. 

• Provide program management expertise during pursuit activities and new client engagements. 

• Identify opportunities to expand existing client relationships and develop additional service offerings. 

• Represent Veranex through industry conferences, webinars, client workshops, and thought leadership activities. 

Team Leadership & Mentorship 

• Mentor project and program managers in software delivery best practices and client engagement strategies. 

• Foster a culture of accountability, collaboration, and continuous learning across delivery teams. 

• Support talent development, performance management, and capability-building initiatives within the Program Management organization. 

Qualifications 

Required Qualifications 

• Bachelor's degree in Engineering, Computer Science, Information Systems, or related technical discipline. 

• Minimum of 12+ years of experience in program or project management with a focus on software development and regulated product development. 

• Demonstrated experience leading complex software development programs for medical devices, digital health technologies, connected health platforms, or Software as a Medical Device (SaMD) products. 

• Strong client-facing consulting experience with responsibility for program delivery, customer satisfaction, and financial performance. 

• Proven ability to manage multiple concurrent projects, priorities, and stakeholder groups within a dynamic consulting environment. 

• Experience leading cross-functional teams including software engineering, systems engineering, cybersecurity, quality assurance, regulatory affairs, and product management. 

• Strong knowledge of Agile, Scrum, hybrid, and traditional software development methodologies. 

• Experience developing project plans, managing budgets, tracking program KPIs, and reporting to executive stakeholders. 

• Exceptional communication, facilitation, negotiation, and presentation skills. 
• Strong analytical and problem-solving capabilities with a proactive approach to risk management and issue resolution. 

Regulatory & Technical Expertise 

• Working knowledge of FDA, EU MDR, ISO 13485, IEC 62304, ISO 14971, IEC 82304, and related medical device software development standards. 

• Experience supporting Design Controls, Software Development Lifecycle (SDLC), requirements management, software verification and validation, traceability, and risk management activities. 

• Understanding of cybersecurity requirements and software quality practices for connected medical devices and digital health solutions. 

• Familiarity with software development tools and environments, including Agile planning platforms, requirements management systems, and defect tracking tools. 

• Understanding of cloud architectures, mobile applications, embedded software systems, and connected device ecosystems. 

Preferred Qualifications 

• PMP, PgMP, PMI-ACP, Scrum Master, or equivalent project management certification. 

• Advanced degree in Engineering, Computer Science, Biomedical Engineering, Business Administration, or related field. 

• Experience working within engineering consulting, product development consulting, or contract development organizations. 

• Experience leading global or distributed software development teams. 
• Experience supporting AI-enabled healthcare, digital therapeutics, remote patient monitoring, or connected medical device platforms.

Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy,  gender identity or gender expression), sexual orientation,  parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics. Applicants must be currently authorized to work in the United States on a full-time basis. The company is not able to sponsor visas or provide employment-based immigration sponsorship for this role now or in the future.

Protecting Your Job Search (Recruitment Scam Awareness)

At Veranex, we believe our people are what set us apart, and our commitment to supporting talent begins the moment you consider joining our team. We aim to provide every candidate with a safe and transparent recruiting experience. As phishing and recruitment scams continue to target job seekers worldwide, here are a few items to keep in mind:

• Official communications will only come from company email addresses ending in @veranex.com.
• We will never ask you to send money or provide banking information at any stage of the recruitment process.
• Be cautious of unexpected emails and avoid opening suspicious links or attachments.
• When in doubt, contact us. If you have questions about the authenticity of a communication you've received, please contact our recruiting team at careers@veranex.com before responding