via LinkedIn Puerto Rico
$70K - 120K a year
Lead and manage project development, scope refinement, scheduling, and risk planning.
Requires a university degree in engineering or similar, experience in regulated industries, and knowledge of quality standards like ISO 13485.
What you will do: • Lead the team in the development of the project charter and management plan. Direct, manage, monitor, and control project. Evaluate tradeoffs within project. • Meet with project stakeholders to understand and refine project scope; review with manager for approval. Create detailed Work Breakdown Structure. • Develop and manage the detailed project Gantt chart. Analyze critical path and major workstreams. • Develop a risk management plan for the project. Identify, analyze and understand project risks, develop and monitor a risk response plan. What you will need: Required: • University degree in engineering (or similar). • Experience in regulated industries, such as medical devices or pharmaceuticals. • Understanding of manufacturing processes and quality tools such as FMEA (Failure Mode and Effects Analysis), CAPA (Corrective and Preventive Actions), PPAP (Production Part Approval Process), validations, and inspections. • Knowledge of standards such as ISO 13485 (quality standard for medical devices). • Advanced English communication skills Desirable: • Experience with Process Flow Mapping (PFM) or process risk assessment. • Experience with non-conformity management.
This job posting was last updated on 12/12/2025