Device Development Lead, Associate Director
Takeda
September 02, 2026
On-site
Lexington, MA
$154,400 - $242,550 USD yearly
Operations
Responsibilities:
- Accountable for device program execution; translate 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.
- Work with Device Project Managers (DPM) to plan and execute project plans.
- Lead cross-functional device teams through clinical development, product registration, commercialization, and potentially Life Cycle Management (LCM).
- Create/manage integrated device development project plans; build cross-functional consensus.
- Drive and manage budgeting and resource deployment (OPEX/spend, CAPEX, FTE).
- Monitor program risk; communicate and propose risk mitigation.
- Report status to DPT/GPT and leadership committees; maintain visibility/transparency.
- Ensure alignment with Stage Gate Milestone framework and Design Transfer readiness.
- Lead TDP/TPP alignment; manage device governance representation; support business reviews, scenario planning, and evaluations.
- Provide direction on device requirements; align with global commercial teams; support digital health/connected care initiatives as needed.
- Oversee quality assurance and compliance with SOPs and external regulatory standards.
- Build relationships with internal/external partners (R&D, manufacturing, OEMs, clinical, QA, procurement, BD, research/brand).
- Execute device program strategy; lead strategic plans (Long Range, LCM, geographic expansion).
Qualifications (Education/Experience):
- BS/BEng in relevant engineering/scientific field + 12+ years relevant experience.
- Device development and commercialization leadership in biotech/pharma or medical device; end-to-end capital equipment development required.
- Experience leading global/enterprise-wide, multi-site programs; manage programs across development stages.
Required/Preferred Skills:
- Strong regulatory knowledge across device lifecycle; quality management systems.
- Strong planning/decision-making; program management tools (integrated plans, timelines, risk, budgeting).
- Leadership and ability to translate strategy into deliverables; consensus building.
- Knowledge of FDA/EU MDR; Microsoft Project.
Benefits:
- Medical/dental/vision insurance, 401(k) match, short-/long-term disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, up to 80 hours sick time/year, up to 120 hours paid vacation (new hires).
Location:
- Lexington, MA.
Application instructions:
- Click “Apply” to begin the employment application process and submit information per Takeda’s Privacy Notice and Terms of Use.
- Accountable for device program execution; translate 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.
- Work with Device Project Managers (DPM) to plan and execute project plans.
- Lead cross-functional device teams through clinical development, product registration, commercialization, and potentially Life Cycle Management (LCM).
- Create/manage integrated device development project plans; build cross-functional consensus.
- Drive and manage budgeting and resource deployment (OPEX/spend, CAPEX, FTE).
- Monitor program risk; communicate and propose risk mitigation.
- Report status to DPT/GPT and leadership committees; maintain visibility/transparency.
- Ensure alignment with Stage Gate Milestone framework and Design Transfer readiness.
- Lead TDP/TPP alignment; manage device governance representation; support business reviews, scenario planning, and evaluations.
- Provide direction on device requirements; align with global commercial teams; support digital health/connected care initiatives as needed.
- Oversee quality assurance and compliance with SOPs and external regulatory standards.
- Build relationships with internal/external partners (R&D, manufacturing, OEMs, clinical, QA, procurement, BD, research/brand).
- Execute device program strategy; lead strategic plans (Long Range, LCM, geographic expansion).
Qualifications (Education/Experience):
- BS/BEng in relevant engineering/scientific field + 12+ years relevant experience.
- Device development and commercialization leadership in biotech/pharma or medical device; end-to-end capital equipment development required.
- Experience leading global/enterprise-wide, multi-site programs; manage programs across development stages.
Required/Preferred Skills:
- Strong regulatory knowledge across device lifecycle; quality management systems.
- Strong planning/decision-making; program management tools (integrated plans, timelines, risk, budgeting).
- Leadership and ability to translate strategy into deliverables; consensus building.
- Knowledge of FDA/EU MDR; Microsoft Project.
Benefits:
- Medical/dental/vision insurance, 401(k) match, short-/long-term disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, up to 80 hours sick time/year, up to 120 hours paid vacation (new hires).
Location:
- Lexington, MA.
Application instructions:
- Click “Apply” to begin the employment application process and submit information per Takeda’s Privacy Notice and Terms of Use.