This position applies advanced professional knowledge of the Business Project Management area to execute and oversee end to end molding projects using established methods and tools, delivering reliable, high quality outcomes.
To lead injection molding related projects, including new molds, mold transfers, mold modifications, and mold duplications. The role may also lead other types of projects based on business needs.
MAJOR RESPONSIBILITIES
- Develop and maintain project plans, timelines, milestones, budgets, resource requirements, risk assessments, and acceptance criteria.
- Coordinate cross-functional activities involving Engineering, Quality, Manufacturing, Product Development, Procurement, PDS&T and external suppliers.
- Monitor project progress, deliverables, dependencies, and critical-path activities to ensure timely execution.
- Identify, communicate, and escalate technical risks, schedule delays, resource constraints, and issues that may affect product launches or supply continuity. Lead project reviews and maintain clear visibility of project status, risks, and recovery plans.
- Assess suppliers’ technical capabilities to design, build, maintain, and operate injection molds for medical device components.
- Identify suppliers’ documentation and technical gaps and establish action plans to close them.
- Develop and execute mold testing and qualification plans, from initial sampling and process development through formal qualification runs.
- To liaise with the suppliers in technical troubleshooting and corrective actions related to mold performance, dimensional variation, cosmetic defects, and process instability.
- Develop the technical qualification and validation strategy in collaboration with the internal/external parties and in accordance with the applicable quality system procedures and regulatory requirements.
- Coordinate Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), as applicable to the approved validation strategy and scope.
- Ensure qualification results meet approved acceptance criteria and that deviations are appropriately investigated and resolved.
- Coordinate root cause investigations and corrective action plans for issues identified during mold development and qualification.