Sustaining Program Manager, Medical Devices & SaMD

Philips Iberica SAU; Cambridge (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

A leading medical technology company is searching for a Program Manager (Sustaining) based in Cambridge, MA. In this role, you will lead the sustainment programs of medical devices, ensuring compliance and quality while managing cross-functional teams. The ideal candidate will have over 7 years of experience in software medical device product development and demonstrate strong communication skills to manage diverse stakeholders. Knowledge of medical device regulations such as ISO 13485 and IEC 62304 is essential. US work authorization is required, and relocation benefits will not be provided.

Qualifications

• 7+ years of experience in software medical device product development or program/project management.
• Hands-on experience managing in-market products and their sustenance.
• Strong knowledge of medical device regulations and standards.

Responsibilities

• Lead sustainment programs ensuring delivery within scope, schedule, and budgets.
• Manage program execution with rigor across multiple projects.
• Ensuring regulatory compliance across all sustainment activities.

Skills

Software medical device product development

Program or project management

Post-market surveillance

Complaint handling/CAPA

Medical device regulations (ISO 13485, IEC 62304, ISO 14971)

Communication and influencing skills

Job description

A leading medical technology company is searching for a Program Manager (Sustaining) based in Cambridge, MA. In this role, you will lead the sustainment programs of medical devices, ensuring compliance and quality while managing cross-functional teams. The ideal candidate will have over 7 years of experience in software medical device product development and demonstrate strong communication skills to manage diverse stakeholders. Knowledge of medical device regulations such as ISO 13485 and IEC 62304 is essential. US work authorization is required, and relocation benefits will not be provided.