Technical Program Manager

Intelex Technologies Ulc; Bengaluru; Presencial; INR 3.000.000 - 5.000.000; Jornada completa

Descripción de la vacante

Intelex Technologies Ulc seeks a Senior Project Manager to lead software releases and regulated medical device product development at the Bangalore IDC, coordinating global teams and ensuring compliance with business, quality, cybersecurity, and regulatory requirements.

On-site in Bangalore IDC, the role focuses on planning, execution, and lifecycle management of releases, with emphasis on design controls, risk management, and cross-functional collaboration for timely commercialization.

Formación

• Experience in regulated product development and design controls.
• Knowledge of 21 CFR Part 820 and ISO 13485 preferred.
• Proven ability to manage complex software or medical device releases.
• Ability to drive governance and stakeholder alignment.

Responsabilidades

• Lead integrated release plans from scope through deployment and post-release follow-up.
• Guide software-enabled medical device products from concept to regulatory submission and lifecycle management.
• Ensure readiness and compliance across design control, quality, risk, cybersecurity, and regulatory areas.
• Coordinate cross-functional teams across Engineering, Regulatory Affairs, Quality, and Operations.

Conocimientos

Regulated environment

Agile delivery

Cross-functional leadership

Risk management

Traceability

Regulatory knowledge

Educación

High School

Associate Degree

Bachelor's Degree

Master's Degree

PhD Degree

Engineering / Life Sciences

Advanced degree

Herramientas

Jira

Confluence

Microsoft Project

Miro

Descripción del empleo

Job Summary

ASP is seeking a Senior Project Manager based on-site at the Bangalore India Development Center (IDC) to lead software releases and medical device product development from planning through commercial release and lifecycle management. This role coordinates global, cross-functional teams and ensures products and releases meet business, customer, quality, cybersecurity, and regulatory requirements.

Location: On-site, Bangalore IDC, India

What Success Looks Like

• Software and medical device releases are planned and delivered predictably, with clear scope, ownership, readiness criteria, and decision points.
• Products are developed and released in compliance with applicable design controls, quality system procedures, risk management processes, and regulatory requirements.
• Risks, dependencies, defects, and resource constraints are identified early and actively managed.
• Local and global teams remain aligned through clear communication, effective governance, and shared accountability.

Duties and Responsibilities

• Lead Product and Software Releases: Own integrated release plans and calendars from scope definition through readiness review, deployment or commercial release, and post-release follow-up.
• Lead Regulated Medical Device Programs: Guide software-enabled medical device products and product changes from concept through development, verification and validation, regulatory submission or clearance, launch, and lifecycle management.
• Ensure Release Readiness and Compliance: 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.
• Drive Cross-Functional Execution: Align Engineering, Systems, Quality, Regulatory Affairs, Cybersecurity, Product Management, Operations, Marketing, Service, Support, and external partners on scope, priorities, resources, timing, and deliverables.
• Strengthen Planning and Predictability: Maintain integrated plans and actively manage milestones, critical path, dependencies, resources, assumptions, and trade-offs across concurrent initiatives.
• Manage Risks, Issues, Defects, and Decisions: Identify concerns early, drive mitigation and resolution, and escalates decisions based on customer, compliance, quality, schedule, and business impact.
• Lead Agile Delivery and Continuous Improvement: Apply Agile and Lean practices appropriate to regulated product development, remove impediments, and use retrospectives and metrics to improve delivery.
• Provide Clear Governance and Communication: Deliver concise, decision-ready updates on program and release health, readiness, risks, dependencies, and required actions to working teams and senior leaders.
• Use Data and FBS Tools: Use Jira, Confluence, dashboards, KPIs, Visual Project Management, risk management, and Kaizen or comparable tools to improve transparency and performance.
• Build a Collaborative Team Environment: Promote trust, shared ownership, accountability, and constructive problem-solving across local and global teams.
• Performs other duties assigned as needed

Responsibilities to Others and Internal Interactions

• Reports to the Director of PMO with a strong dotted-line relationship to Software leadership.
• Leads day-to-day program and release coordination with the Bangalore IDC software organization and global product teams.
• Partners with senior leaders and stakeholders across Software Engineering, Systems, Product Management, Quality, Regulatory Affairs, Cybersecurity, Operations, Marketing, Service, and Support.
• Influences managers and individual contributors across functions without direct authority.

External Interactions

• Coordinates with software development, cloud, cybersecurity, verification, manufacturing, and other external partners as needed.
• Participates in customer, partner, or market engagements to understand product needs and performance, as appropriate.

Qualifications

Education:

• High School or Equivalent
• Associate s Degree
• Bachelor s Degree
• Master s Degree
• PhD Degree
• Bachelor s degree in Engineering, Life Sciences, or a related technical discipline required.
• Preferred Advanced degree (Master s Degree)

Experience

• 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.

Knowledge, Skills, Abilities, Certifications/Licenses, and Affiliations

• Working knowledge of medical device quality and regulatory requirements, including 21 CFR Part 820 and ISO 13485; experience supporting FDA 510(k) submissions or clearances preferred.
• 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.
• PMP, PgMP, PMI-ACP, CSM, SAFe, or equivalent certification preferred.