About this role
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
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.
Responsibility for Others and Internal Interactions
☐ N/A
- 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
☐ N/A
- 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.
Physical & Work Environment Requirements
Physical Requirements:
The physical demands identified are representative of the physical requirements necessary for an employee to successfully perform the essential functions of this job. Reasonable accommodation can be made to enable people with disabilities to perform the described essential functions of this job. While performing the responsibilities of this job, the employee may be required to talk and hear.
Work Environment (mark all that apply)
Travel on the Job: ☒ Domestic ☒ International - ( Travel as needed to support projects, estimated at 15%)
☒ Scheduled Work Hours
☐ Shift Work
☐ On Call (Call in for Work)
Approximate Position Requirements
Standing: 0-10%
Kneeling: 0%
Sitting: Up to 90%
Walking: 0-10%
Additional Work Environment Requirements
☒ N/A
Location: On-site; Bangalore IDC, India
Environmental, Health and Safety
All managers and employees shall proactively support ASP’s 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.
Occupational Hazards
Ergonomic Risk: Low Reproductive Health Risk: No Concern
☐ 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
☐ Other Hazards: Click or tap here to enter text.
Powered Industrial Vehicles (PIV) Operation
☒ N/A
☐ Forklift
☐ Motorized Pallet Jack
☐ Company Vehicle
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
Repetitive Hand Motions
☐ N/A
☐ Twisting Motion
☒ Computer Entry
☐ Simple Grasp
☐ Fine Manipulation
Additional Environmental, Health and Safety
☒ N/A
Compliance
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.