Program Manager, NPI

This is a fully remote position, open to applicants in California.

📋 Description

• Oversee intricate cross-functional New Product Introduction (NPI) programs for connected medical devices from initial concept through design, verification and validation, manufacturing transfer, and ongoing support.

• Collaborate with teams across hardware, firmware, mobile/app development, regulatory, quality assurance, and clinical to establish requirements, priorities, project scope, budget, and timelines.

• Lead program-level risk management in accordance with ISO 14971 standards.

• Take ownership of program schedules, design history file milestones, and phase-gate deliverables.

• Address issues, eliminate obstacles, and facilitate decision-making across teams.

• Coordinate Bluetooth/BLE, companion app, and cloud/data integration workstreams in collaboration with software and security teams.

• Formulate recommendations, achieve stakeholder consensus, and relay program status and risks to leadership.

• Assist in design transfer and ensure manufacturing readiness with operations and contract manufacturers.

⛳️ Requirements

• A minimum of 12 years of experience, including at least 5 years in program or project management within the medical devices sector or other regulated hardware/software industries.

• A Bachelor's degree or higher is preferred, or equivalent professional experience.

• Proven experience in leading NPI programs for connected or electro-mechanical medical devices throughout the entire lifecycle, from concept to launch and ongoing support.

• Familiarity with FDA Quality System Regulations (QSR) (21 CFR Part 820), ISO 13485, IEC 62304, and ISO 14971.

• Experience collaborating with regulatory and quality teams to fulfill design control requirements.

• Ability to manage hardware, firmware, and connected software/app workstreams within a unified program.

• Proficiency in using Atlassian tools such as JIRA and Confluence.

• Strong communication skills to clearly convey technical issues and solutions to diverse audiences.

• Extensive knowledge of project management software tools, methodologies, and best practices.

• PMP or PgMP certification is preferred.

• A strong sense of ownership, urgency, and drive.

• An agile approach to project management style and execution.

🏝️ Benefits

• Equal employment opportunities regardless of gender, race, religion, sexual orientation, gender identity, age, marital status, disability, or Veteran status.