Hybrid R&D Program Manager — Medical Device Software

haemonetics; Boston (MA); Hybrid; USD 103,600 - 176,400; Full time

Benefits offered by this job

401(k) with employer match

Employee stock purchase plan

Paid time off

Job summary

Haemonetics is seeking a Program Manager to lead enterprise software initiatives, plan and manage risks, and ensure on-time delivery within budget. The role requires coordinating cross-functional teams, R&D collaboration, and governance across stages from concept to commercialization.

Ideal candidates have 5+ years in program management for software development and experience with medical device development under FDA QSR, CE Marking, and ISO QMS.

Qualifications

• Bachelor's Degree required, BS in Engineering preferred.
• 5+ years Program management experience leading software development programs.
• Program management leading medical device development.
• Experience with medical device development (Class II/III) under FDA Quality Systems Regulations.
• Experience with medical device development under FDA Quality Systems Regulations, CE Marking, and ISO Quality Systems

Responsibilities

• Analyze project risks and identify impact while developing mitigation strategies and manage critical path.
• Create and execute project work plans and revise to meet changing needs.
• Manage day-to-day operational aspects and scope; ensure SOPs and Stage Gate compliance.
• Mitigate team conflict and motivate the team to work efficiently.
• Leverage project management tools to assist in schedule development and status reporting.
• Create governance levels to ensure alignment and clear objectives.
• Accountable for product design history file, regulatory standards, and compliance to QMS procedures.
• Capture and share lessons learned with the team

Skills

Project management

Risk management

Cross-functional collaboration

Communication

Stakeholder management

Education

Bachelor's degree

Engineering degree preferred

Job description

Haemonetics is seeking a Program Manager to lead enterprise software initiatives, plan and manage risks, and ensure on-time delivery within budget. The role requires coordinating cross-functional teams, R&D collaboration, and governance across stages from concept to commercialization.

Ideal candidates have 5+ years in program management for software development and experience with medical device development under FDA QSR, CE Marking, and ISO QMS.