Technical Program Manager

Overview

Lead software releases and regulated medical device product development from planning through commercial release and lifecycle management, based on-site at the Bangalore India Development Center.

What you'll do

• Own integrated release plans and calendars from scope definition through readiness review, deployment or commercial release, and post-release follow-up.
• Guide software-enabled medical device products and product changes from concept through development, verification and validation, regulatory submission or clearance, launch, and lifecycle management.
• Confirm that required design control, quality, risk management, cybersecurity, traceability, verification and validation, regulatory, manufacturing, service, and launch deliverables are complete before release.
• Facilitate documented go/no-go decisions with accountable stakeholders.
• Align Engineering, Systems, Quality, Regulatory Affairs, Cybersecurity, Product Management, Operations, Marketing, Service, Support, and external partners on scope, priorities, resources, timing, and deliverables.
• Maintain integrated plans and actively manage milestones, critical path, dependencies, resources, assumptions, and trade-offs across concurrent initiatives.
• Identify concerns early, drive mitigation and resolution, and escalate decisions based on customer, compliance, quality, schedule, and business impact.
• Apply Agile and Lean practices appropriate to regulated product development, remove impediments, and use retrospectives and metrics to improve delivery.
• Deliver concise, decision-ready updates on program and release health, readiness, risks, dependencies, and required actions to working teams and senior leaders.
• Use Jira, Confluence, dashboards, KPIs, Visual Project Management, risk management, and Kaizen or comparable tools to improve transparency and performance.
• Promote trust, shared ownership, accountability, and constructive problem-solving across local and global teams.
• Perform other duties assigned as needed.

What you'll need

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• 3+ years of project or program management experience leading complex software or product development across global, cross-functional teams.
• 2+ years of experience in the medical device or a similarly regulated industry.
• Demonstrated experience planning and executing recurring software releases, including scope, dependencies, quality gates, readiness reviews, deployment, and post-release improvement.
• Demonstrated knowledge and experience leading medical device products through design controls, verification and validation, regulatory submission or clearance, manufacturing and commercial readiness, product release, and lifecycle changes.
• Experience managing multiple interdependent initiatives and influencing stakeholders without direct authority.
• Hands-on experience with Agile delivery, project metrics, and continuous improvement.
• Working knowledge of medical device quality and regulatory requirements, including 21 CFR Part 820 and ISO 13485.
• Ability to assess and confirm medical device release readiness in a regulated environment, including required approvals, objective evidence, traceability, risk controls, verification and validation, labeling, manufacturing readiness, and change control.
• Strong project and program management skills across scope, schedule, resources, dependencies, critical path, risk, and stakeholder alignment.
• Knowledge of medical device software lifecycle practices, design controls, risk management, cybersecurity, and configuration and change management.
• Strong Agile leadership and the judgment to adapt delivery practices to regulated product development.
• Clear written and verbal communication, with the ability to influence global teams and present decision-ready information to senior leaders.
• Structured problem-solving and sound decision-making using data, root-cause analysis, and business and customer impact.
• Proficiency with Jira, Confluence, Microsoft Project, Miro, Microsoft Office, dashboards, and related collaboration tools.

Nice to have

• Advanced degree (Master's Degree).
• Experience supporting FDA 510(k) submissions or clearances.
• PMP, PgMP, PMI-ACP, CSM, SAFe, or equivalent certification.

Details

• On-site at the Bangalore IDC, India.
• Reports to the Director of PMO with a strong dotted-line relationship to Software leadership.
• Scheduled work hours.
• Travel domestic and international as needed to support projects, estimated at 15%.
• Coordinates with software development, cloud, cybersecurity, verification, manufacturing, and other external partners as needed.