Device Development Lead, Associate Director

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.

• 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).

• Translate strategy into tangible deliverables; manage complex strategic/operational interactions.
• Build consensus; independent, proactive, diplomatic leadership; team player.

• Lexington, MA. U.S. base salary range: $154,400–$242,55o. Eligible for incentives and benefits including medical/dental/vision, 401(k), disability, life insurance, tuition reimbursement, paid time off, holidays, and well-being.