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 escalate 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.

Other Duties: Performs other duties assigned as needed

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, labelling, 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, Protected, or equivalent certification preferred.

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