Job Description:

We are seeking an experienced Program Manager to lead multi-functional teams and manage the design, development, and launch of this product. This role requires strong program leadership, supplier and partner management experience, deep familiarity with design controls and risk management in medical device development, and solid understanding of cloud software and digital services.

Key Responsibilities:

• Lead the end-to-end program execution for Polyphonic Edge from Concept through Launch, ensuring alignment to scope, schedule, cost, quality, and regulatory requirements.
• Act as primary program integrator across hardware engineering teams, embedded software, cloud services, systems/testing, regulatory, quality, manufacturing, procurement, and product teams.
• Lead external design partners, contract manufacturers, and OEM suppliers: define deliverables, milestones, contracts/SLAs, review partner technical work, drive escalation, and verify partner compliance with program and quality expectations.
• Establish, maintain, and report program plans, integrated master schedules, budgets, KPI dashboards, and risk/action logs; provide clear, timely status updates to senior leadership.
• Apply Design Control processes and gate-keeping: drive design reviews, design freezes, change control, verification & validation planning/execution, design history file artifacts, and design transfer activities.
• Lead program risk management activities (e.g., DFMEA, PFMEA, SHA), ensure traceability from requirements to verification/validation.
• Partner with cybersecurity, Infrastructure, other Polyphonic application teams to ensure integration, data security, privacy, non functional requirements are identified and tracked through the program.
• Facilitate cross-functional meetings, remove roadblocks, drive decisions, and ensure prompt closure of actions. 
• Mentor and coach project managers and program coordinators on program management best practices, tools, and J&J processes.

Qualifications

Required:

• A minimum of a BS in Engineering, Computer Science, Systems Engineering, or related technical discipline.
• A minimum of 5 years of program or project management experience in regulated product development (medical device strongly preferred).
• Demonstrated experience managing design partners, contract manufacturers, and external development houses for hardware products.
• Experience coordinating programs that include embedded systems and cloud/software components (SaaS, backend services, or device-to-cloud integration).
• Excellent written and verbal communication skills

Preferred:

• Solid understanding and hands-on application of medical device Design Controls, risk management (ISO 14971), verification & validation, and regulatory pathways.
• PMP certification
• Experience with embedded systems, software development under Agile software delivery models, CI/CD, and software lifecycle processes for regulated software (IEC 62304 experience a plus).