Remote NPI Program Manager - Medical Devices

Ladders

United States

Remote

USD 120,000 - 145,000

Full time

13 hours ago

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Job summary

Ladders is seeking a Program Manager, NPI to lead new product introduction programs for connected medical devices in a highly regulated environment. You will guide initiatives from concept through launch, coordinating hardware, firmware, software, connectivity, and security workstreams.

Location: Remote (US). You will partner with engineering, quality, manufacturing, and leadership teams to drive design transfer, regulatory compliance, and commercialization outcomes, ensuring programs meet ISO

Qualifications

12+ years of project/program management experience in medical devices or regulated industries.
5+ years leading new product introduction (NPI) programs from concept to market.
Familiarity with FDA QSR, ISO 13485, IEC 62304, and ISO 14971 standards.
Proven ability to coordinate hardware, firmware, and software app workstreams effectively.
PMP or PgPg certification preferred.

Responsibilities

Manage complex NPI programs for connected medical devices from concept through launch.
Collaborate across teams to define project scope, budget, and timelines.
Drive program-level risk management in accordance with ISO standards.
Maintain program schedules, DHF milestones, and phase-gate deliverables.
Facilitate cross-team decision making and remove obstacles for successful project execution.
Coordinate device connectivity efforts with software and security teams.
Communicate program status, recommendations, and risks clearly to leadership.
Support design transfer and manufacturing readiness.