Technical Program Manager

Position 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 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:

N/A

Performs other duties assigned as needed

Education:

High School or Equivalent

Associates Degree

Bachelors Degree

Masters Degree

PhD Degree

Bachelors degree in Engineering Life Sciences or a related technical discipline required.

Preferred Advanced degree (Masters 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.

• 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.

• 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.

Scheduled Work Hours

Shift Work

Standing: 0-10%

Kneeling:0%

Sitting: Up to 90%

Walking: 0-10%

All managers and employees shall proactively support ASPs Environmental Health and Safety (EHS) Policy by providing the necessary resources and giving equal emphasis with other functions such as production and quality. It is the duty of every manager and employee to:

Ensure implementation of safety and environmental procedures guidelines and standards.

Evaluate employee compliance and enforce established safety and environmental procedures and rules.

Create a safe work area environment recognize safe activities and reward good safety performance.

Provide training to employees when:

• Hired
• Transferred
• New substances processes procedures or equipment are introduced to the workplace and represent a new hazard

Measure safety performance and hold persons accountable for activities and results.

Ensure that incidents are investigated to determine root cause and that corrective actions are taken.

Ensure employees wear required protective equipment.

Ensure EHS inspections are conducted monthly and corrective actions are implemented.

Machine Operation

Electrical Hazards

Laser Hazards

Excessive Noise (>85 dB)

Heights (> 6ft)

Hazardous Chemicals/Fumes

Excessive Dust

Bloodborne Pathogen

Biohazards(BBP and parts of LAH)

Extreme Heat/Cold

N/A

Forklift

Motorized Pallet Jack

Lifting Requirement

N/A

Choose an item.

Ground to knees

Ground to Waist

Ground to Shoulders

Ground to Overhead

Waist to Shoulders

Waist to Overhead

Twisting Motion

Computer Entry

Simple Grasp

Fine Manipulation

All employees have a duty to comply with applicable laws regulations standards ASP policies and procedures.

This job description is intended to convey information essential to understanding the scope of this position and it is not intended to be an exhaustive list of skills efforts duties responsibilities or working conditions associated with the position.Employees are required to follow any other job-related instructions and perform job-related duties as may be reasonably assigned by his/her supervisor. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential duties of the job.