Device Development Lead, Associate Director

Scorpion Therapeutics; Lexington (MA); On-site; USD 154,000 - 243,000; Full time

Benefits offered by this job

Medical benefits

401(k)

Tuition reimbursement

Paid time off

Job summary

Scorpion Therapeutics in Lexington, MA seeks an experienced leader to drive device program execution from strategy to delivery. You will partner with global teams, manage cross-functional plans, and guide the program through development, registration, and lifecycle activities.

The role requires 12+ years in device development with enterprise-wide leadership, strong regulatory knowledge (FDA/EU MDR), and proficient use of integrated development tools.

Qualifications

• BS/BEng in relevant field with 12+ years experience.
• Device development and commercialization leadership across global programs; end-to-end capital equipment development.
• Proven leader managing complex cross-functional teams across development stages.
• Regulatory knowledge for devices incl. FDA/EU MDR; planning and decision-making.

Responsibilities

• Translate product development strategy into actionable device program plans and deliverables.
• Partner with Device Program Teams (DPTs) and 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, registration, commercialization, and Life Cycle Management.
• 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.

Skills

Cross-functional leadership

Regulatory knowledge

Global program management

Budgeting & resource planning

Education

BS/BEng in engineering/science

Tools

Microsoft Project

Job description

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–$242,55o. Eligible for incentives and benefits including medical/dental/vision, 401(k), disability, life insurance, tuition reimbursement, paid time off, holidays, and well-being.