Device Development Lead, Associate Director
Takeda
August 12, 2026
On-site
Lexington, MA
$154,400 - $242,550 USD yearly
Clinical Research and Development
Responsibilities:
- Accountable for device program execution, translating product development strategy into actionable plans/deliverables.
- Partner with Device Program Teams (DPTs) and drug Global Program Teams (GPTs) to align device strategy and execution.
- Collaborate with Device Project Managers (DPMs) to plan and execute project plans.
- Lead cross-functional device teams through clinical development, product registration, commercialization, and (as applicable) Life Cycle Management (LCM).
- Create, manage, and execute integrated device development project plans; build consensus across teams.
- Drive budgeting (OPEX/spend, CAPEX, FTE) and resource deployment.
- Monitor program risk; provide mitigation solutions and communicate status to leadership bodies.
- Ensure alignment to Stage Gate Milestone framework; support Design Transfer readiness.
- Lead TDP/TPP alignment; represent device team in governance bodies.
- Ensure QA compliance with internal SOPs and external regulatory standards; oversee subcontractor/CMO compliance.
Qualifications (Required/Preferred):
- BS/BEng in relevant engineering/scientific field + 12+ years relevant experience.
- Device development and commercialization experience leading global/enterprise-wide, multi-site programs; end-to-end capital equipment development required.
- Proven leader managing complex cross-functional teams; experience across development stages.
- Strong regulatory knowledge for devices across lifecycle; planning/decision-making competence; program management tools (integrated development plans, timelines, risk, budgets).
- Strong understanding of global device development/commercialization in pharma (preferred); medical device product development process and FDA/EU MDR; Microsoft Project (familiarity).
Key Skills/Abilities:
- Translate strategy into tangible deliverables; manage complex strategic/operational interactions.
- Build consensus; independent, proactive, diplomatic leadership; team player.
Compensation/Benefits (as stated):
- Lexington, MA. U.S. base salary range: $154,400–$242,550. Eligible for incentives and benefits including medical/dental/vision, 401(k), disability, life insurance, tuition reimbursement, paid time off, holidays, and well-being.
Application Instructions:
- Apply via the “Apply” button.
- Accountable for device program execution, translating product development strategy into actionable plans/deliverables.
- Partner with Device Program Teams (DPTs) and drug Global Program Teams (GPTs) to align device strategy and execution.
- Collaborate with Device Project Managers (DPMs) to plan and execute project plans.
- Lead cross-functional device teams through clinical development, product registration, commercialization, and (as applicable) Life Cycle Management (LCM).
- Create, manage, and execute integrated device development project plans; build consensus across teams.
- Drive budgeting (OPEX/spend, CAPEX, FTE) and resource deployment.
- Monitor program risk; provide mitigation solutions and communicate status to leadership bodies.
- Ensure alignment to Stage Gate Milestone framework; support Design Transfer readiness.
- Lead TDP/TPP alignment; represent device team in governance bodies.
- Ensure QA compliance with internal SOPs and external regulatory standards; oversee subcontractor/CMO compliance.
Qualifications (Required/Preferred):
- BS/BEng in relevant engineering/scientific field + 12+ years relevant experience.
- Device development and commercialization experience leading global/enterprise-wide, multi-site programs; end-to-end capital equipment development required.
- Proven leader managing complex cross-functional teams; experience across development stages.
- Strong regulatory knowledge for devices across lifecycle; planning/decision-making competence; program management tools (integrated development plans, timelines, risk, budgets).
- Strong understanding of global device development/commercialization in pharma (preferred); medical device product development process and FDA/EU MDR; Microsoft Project (familiarity).
Key Skills/Abilities:
- Translate strategy into tangible deliverables; manage complex strategic/operational interactions.
- Build consensus; independent, proactive, diplomatic leadership; team player.
Compensation/Benefits (as stated):
- Lexington, MA. U.S. base salary range: $154,400–$242,550. Eligible for incentives and benefits including medical/dental/vision, 401(k), disability, life insurance, tuition reimbursement, paid time off, holidays, and well-being.
Application Instructions:
- Apply via the “Apply” button.