Medical Device Software Program Manager

haemonetics; United States; On-site; USD 104,000 - 176,000; Full time

Benefits offered by this job

401(k) matching up to 6%

Employee stock purchase plan

Flexible time off for salaried; 3–5 wk

Paid holidays

Sick time

Parental leave

Disability insurance

Tuition reimbursement

Health and welfare benefits

Job summary

Haemonetics is seeking a Program Manager to lead complex software development programs for medical device products in regulated environments, coordinating on-premises and cloud platforms, and ensuring compliance with FDA, ISO 13485, IEC 62304 throughout the lifecycle.

You will partner with Software Engineering, Quality, Regulatory Affairs, Cybersecurity, Product Management, Clinical, and Operations to deliver enterprise software solutions, manage risks, timelines, and budgets, and drive lean

Responsibilities

• Lead complex software programs for medical devices in regulated environments, ensuring compliance with FDA/ISO 13485/IEC 62304.
• Manage on-premises and cloud software programs, coordinating architecture, validation, deployment, and releases with cross-functional teams.
• Analyze risks, assess impact, develop mitigations, manage critical paths, and lead programs from concept to commercialization.
• Create and execute project plans, adjusting scope, schedules, and resources to meet evolving requirements.
• Manage day-to-day operations while ensuring Stage-Gate, quality systems, and SOP compliance; escalate risks.
• Collaborate with Software Eng, Quality, Regulatory, Cybersecurity, PM, Clinical, and Ops to deliver enterprise software for medical devices.
• Drive continuous improvement with Lean/Six Sigma to improve quality, efficiency, and delivery.
• Establish and monitor program KPIs and dashboards to identify risks and support data-driven decisions.
• Coordinate V&V, traceability, documentation, and release readiness for regulated medical device software.
• Plan deployment/implementation for on-prem and cloud while ensuring security, compliance, and quality.
• Standardize processes across dev teams to streamline workflows and improve quality.
• Use PM tools to develop and communicate schedules, milestones, dependencies, and status.
• Establish governance structures for alignment and decision-making.
• Maintain accountability for Design History File (DHF) deliverables.

Job description

Haemonetics is seeking a Program Manager to lead complex software development programs for medical device products in regulated environments, coordinating on-premises and cloud platforms, and ensuring compliance with FDA, ISO 13485, IEC 62304 throughout the lifecycle.

You will partner with Software Engineering, Quality, Regulatory Affairs, Cybersecurity, Product Management, Clinical, and Operations to deliver enterprise software solutions, manage risks, timelines, and budgets, and drive lean