Senior Medical Device R&D Program Lead

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

Benefits offered by this job

401(k) with employer match

Employee stock purchase plan

Flexible time off

Paid vacation & sick time

Holidays & parental leave

Disability insurance

Tuition reimbursement

Health benefits

Job summary

Haemonetics Corp is seeking a Program Manager to plan, execute, and commercialize Enterprise Software projects for medical devices. You will manage cross-functional teams, meet strict deadlines, and ensure FDA/ISO/QMS compliance across on-prem and cloud platforms. Preference for candidates in Massachusetts or the Northeast region.

The role emphasizes risk management, governance, and continuous improvement using Lean Six Sigma. Strong communication with executive stakeholders is essential.

Qualifications

• Bachelor's degree required; engineering, CS or related technical discipline preferred.
• 7+ years of program or project management experience in regulated environments.
• Experience leading enterprise software programs for medical devices is preferred.
• Experience with cloud and on-prem deployments and lifecycle management.
• Strong understanding of SDLC, Agile, and cybersecurity in regulated settings.

Responsibilities

• Lead complex software development programs for medical device products.
• Coordinate cross-functional teams across architecture, validation, deployment.
• Manage risk, schedules, and budgets with Stage-Gate processes.
• Develop and monitor program metrics, KPIs, and dashboards.
• Ensure regulatory compliance with FDA, ISO 13485, and QMS requirements.
• Drive Lean Six Sigma and continuous improvement initiatives.

Skills

Program management

Cross-functional leadership

Regulated software

Executive communication

Stakeholder management

Education

Bachelor's degree in Engineering/CS

Tools

AWS

Azure

GCP

DevOps

Job description

Haemonetics Corp is seeking a Program Manager to plan, execute, and commercialize Enterprise Software projects for medical devices. You will manage cross-functional teams, meet strict deadlines, and ensure FDA/ISO/QMS compliance across on-prem and cloud platforms. Preference for candidates in Massachusetts or the Northeast region.

The role emphasizes risk management, governance, and continuous improvement using Lean Six Sigma. Strong communication with executive stakeholders is essential.