Senior Device Development Program Lead

Takeda; Lexington (MA); On-site; USD 154,400 - 242,550; Full time

Job summary

Takeda in Lexington, MA seeks a senior device development leader to drive end-to-end program plans, coordinate with global teams, and ensure regulatory and quality compliance. The role requires guiding cross-functional teams across device development, lifecycle management, and launch readiness.

You will lead budgeting and resource planning, oversee governance forums, and align strategies with market needs and Stage Gate milestones.

Qualifications

• BS/BEng in relevant engineering or scientific field with 12+ years in device development.
• Experience leading cross-functional, global programs in biotech/pharma or medical devices.
• End-to-end development experience with capital equipment required.
• Strong leadership to manage multiple cross-functional teams and processes.

Responsibilities

• Lead and drive development and execution of device program plans with cross-functional teams.
• Drive budgeting and ensure resource deployment (OPEX/CAPEX/FTE).
• Represent device development team at Takeda’s product governance bodies (GPT, PDT).
• Ensure alignment with Stage Gate milestones and Design Transfer readiness.
• Promote visibility and transparency across the device development team.
• Collaborate with global commercial teams for market needs and launch readiness.
• Oversee quality assurance and regulatory compliance.

Skills

Device program management

Cross-functional leadership

Budgeting and planning

Regulatory knowledge

Risk management

Global coordination

Education

BS/BE in engineering or sciences

Tools

Microsoft Project

PM tools

Job description

Takeda in Lexington, MA seeks a senior device development leader to drive end-to-end program plans, coordinate with global teams, and ensure regulatory and quality compliance. The role requires guiding cross-functional teams across device development, lifecycle management, and launch readiness.

You will lead budgeting and resource planning, oversee governance forums, and align strategies with market needs and Stage Gate milestones.