Direct cross-functional internal teams, external vendors, suppliers, and strategic partners.
Build team ownership and commitment to projects and assign clear authority, accountability, and deliverables.
Drive all phases of the product development cycle.
Develop and monitor project budgets, internal billing, and TCOGS.
Maintain alignment with clinicians, customers, internal teams, and FM key stakeholders.
Identify constraints and risks, maintain credible schedules, align with CCPM/PCE practices.
Measure, report and improve program KPIs, demonstrate cost reduction through process optimization.
Develop and maintain compliant design/process documentation.
Mentor and support engineering staff development while fostering a high-performing, collaborative project culture.
Evaluate new business opportunities and lead quoting and proposal development.

Bachelor's/University degree in Engineering, Chemistry, Biology, or related science/technical field.
8+ years’ experience in Medical Device or related industry.
6+ years’ experience in Project/Program Management in a manufacturing environment.
Prior experience with silicone material, plastics, and/or extrusions.
In-depth understanding of engineering and manufacturing processes used in medical device production.
Advanced experience with engineering/statistical problem-solving methodologies.
Deep understanding of ISO standards, particularly ISO 13485, ISO 14001, ISO 14971.
Knowledge of GMP principles and their application in medical device manufacturing.
Demonstrated experience using Lean/Six Sigma tools.
Demonstrated experience providing leadership and managing full development programs or multiple projects of high complexity.

Program Manager – Medical Device

Key skills