Summary

Responsibilities

• Lead cross-functional core teams through all phases of product development and commercialization.

• Develop integrated business and commercialization plans supporting global product launch strategies.

• Plan, schedule, and manage project activities to meet objectives and compliance requirements.

• Track and manage project budgets, schedules, and ROI targets.

• Build strong partnerships with functional leaders and key stakeholders.

• Promote a culture of innovation, accountability, and results.

• Provide strategic guidance, structured thinking, and clear delegation to project teams.

• Mentor and coach project managers, core team leaders, and team members.

• Drive process adherence, best‑practice project management, and continuous improvement initiatives.

• Facilitate effective decision making using sound judgment and scenario evaluation.

• Provide input to annual planning regarding resource needs for development initiatives.

Essential Functions of the Role

Education & Work Requirements

Education & Work Preferences

• Technical Bachelor’s degree required.

• 8–10 years of experience managing complex product development projects, preferably in medical devices.

• Minimum 5 years leading projects or cross‑functional teams.

• Experience with product development, commercialization, and enterprise‑level process initiatives.

• Knowledge of regulatory environments, including 21 CFR, QSR 830, ISO 13485, and ISO 14971.

• Master’s degree (e.g., MS, MBA, Engineering) preferred.

• PMP certification preferred.

• Experience in risk management, quality systems, and enterprise‑wide process improvement.

• Experience in matrixed environments with multiple stakeholder groups.

Competencies