Program Manager, NPI

Jobgether; Deutschland; Remote; EUR 121.000 - 181.000; Vollzeit

Benefits dieser Stelle

Remote work US

Impactful projects

Collaborative culture

Career growth

Zusammenfassung

Jobgether partnership seeks a Program Manager, NPI in the United States to lead the development and launch of connected medical devices focused on women’s health. You will orchestrate hardware, firmware, software, regulatory, quality, clinical and manufacturing teams from concept through design, verification, validation, transfer, launch and sustaining.

The role demands ownership, risk management, and clear executive communication to keep programs on schedule while ensuring safety and regulatory

Qualifikationen

• 12+ years in professional experience, incl. 5+ years in medical devices program management.
• Bachelor's degree or higher or equivalent combination of education and relevant experience.
• Experience leading new product introduction programs for connected or electro-mechanical medical devices through the complete product lifecycle.
• Working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, IEC 62304, ISO 14971.
• Experience coordinating hardware, firmware, mobile/app, and connected software workstreams.
• Proven ability to coordinate complex cross-functional programs with multiple stakeholders.
• Proficiency with JIRA, Confluence, SmartSheet, or comparable platforms.
• PMP or PgMP certification preferred.

Aufgaben

• Lead complex cross-functional new product introduction programs for connected medical devices from concept through launch and sustaining.
• Partner with hardware, firmware, mobile/app, regulatory, quality, clinical, manufacturing and other teams to set requirements, schedules and milestones.
• Drive program-level risk management per ISO 14971 and communicate risks to leadership.
• Maintain integrated program schedules and DHF milestones with Quality/Regulatory.
• Coordinate device connectivity initiatives across hardware and software.
• Develop recommendations and secure stakeholder alignment with clear progress updates.
• Support design transfer and manufacturing readiness with Operations and contract manufacturers.
• Ensure design control, regulatory and product development requirements are met.

Kenntnisse

Leadership

Communication

Agile project management

Stakeholder management

Regulatory knowledge

Risk management

Cross-functional coordination

Project management tools

Problem solving

Ausbildung

Bachelor's degree

Tools

JIRA

Confluence

SmartSheet

Jobbeschreibung

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Program Manager, NPI based in the United States.

This is a high-impact opportunity to lead the development and launch of connected medical devices designed to improve women's health. The role sits at the center of multidisciplinary product development, bringing together hardware, firmware, software, regulatory, quality, clinical, and manufacturing teams. You will own complex new product introduction programs from early concept through design, verification, validation, manufacturing transfer, launch, and sustaining. The position combines strategic program leadership with hands-on execution, risk management, and cross-functional decision-making. You will help ensure products meet demanding safety, quality, regulatory, technical, and commercial requirements while staying on schedule. Working in a mission-driven and innovative environment, you will serve as a force multiplier for functional leaders and help remove obstacles across the organization. This role is ideal for an experienced medical device program leader who thrives on ownership, urgency, collaboration, and bringing sophisticated connected products to market.

Accountabilities

• Lead complex cross-functional new product introduction programs for connected medical devices from concept and feasibility through design, verification and validation, manufacturing transfer, launch, and sustaining.
• Partner with hardware, firmware, mobile/app, regulatory, quality, clinical, manufacturing, and other functional teams to establish program requirements, priorities, scope, budgets, schedules, and milestones.
• Drive program-level risk management in accordance with ISO 14971, proactively identifying, assessing, mitigating, and communicating technical, regulatory, quality, and schedule risks.
• Own and maintain integrated program schedules, design history file milestones, phase-gate deliverables, and other critical program documentation in partnership with Quality and Regulatory teams.
• Serve as a force multiplier for functional leaders by identifying obstacles, coordinating issue resolution, facilitating decisions, and maintaining momentum across workstreams.
• Coordinate device connectivity initiatives, including Bluetooth/BLE, companion applications, cloud integrations, and data-related workstreams, ensuring cohesive integration across hardware and software.
• Facilitate cross-functional planning and decision-making to keep technical and operational teams aligned with overall program objectives.
• Develop recommendations based on program data and technical considerations, secure stakeholder alignment, and communicate progress, risks, dependencies, and decisions clearly to leadership.
• Support design transfer and manufacturing readiness activities in partnership with Operations, manufacturing teams, and contract manufacturers.
• Ensure program execution remains aligned with applicable design control, quality, regulatory, and product development requirements.
• Apply structured project management methodologies and tools to monitor deliverables, identify risks, track dependencies, and maintain accountability.
• Drive execution with a strong sense of ownership and urgency while adapting program plans to changing technical, regulatory, and business requirements.

Requirements

• 12 years of professional experience, including at least 5 years in program or project management within medical devices or another highly regulated hardware/software industry.
• Bachelor's degree or higher preferred, or equivalent combination of education and relevant experience.
• Demonstrated experience leading new product introduction programs for connected or electro-mechanical medical devices through the complete product lifecycle, from concept through launch and sustaining.
• Working knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, IEC 62304, and ISO 14971.
• Experience partnering closely with Regulatory and Quality teams to execute design controls and maintain compliance throughout product development.
• Proven ability to coordinate hardware, firmware, mobile/application, and connected software workstreams within a single integrated program.
• Experience managing complex cross-functional programs involving multiple technical and functional stakeholders.
• Proficiency with project management and collaboration tools such as JIRA, Confluence, SmartSheet, or comparable platforms.
• Strong understanding of program management methodologies, processes, and best practices.
• Excellent communication skills, with the ability to explain complex technical problems, trade-offs, risks, and solutions to audiences across all organizational levels.
• Strong stakeholder management and facilitation skills, with the ability to build alignment and drive decisions across diverse teams.
• High level of ownership, urgency, accountability, and initiative.
• Agile and adaptable project management approach, with the ability to respond effectively to changing priorities and emerging challenges.
• Strong organizational and analytical skills, with the ability to manage multiple workstreams, milestones, dependencies, and risks simultaneously.
• PMP or PgMP certification is preferred.

Benefits

• Remote work opportunity within the United States.
• Opportunity to lead innovative connected medical device programs with meaningful potential impact on women's health.
• Mission-driven and collaborative work environment focused on innovation and improving patient and user outcomes.
• Cross-functional exposure to hardware, software, firmware, clinical, regulatory, quality, and manufacturing disciplines.
• Opportunity to influence products throughout the full lifecycle, from early concept through commercialization and sustaining.
• Professional growth opportunities through involvement in complex, multidisciplinary programs.
• Inclusive workplace committed to equal employment opportunities and a diverse workforce.
• Supportive environment for experienced professionals who value ownership, collaboration, and innovation.