- Provides leadership to manage multiple projects and production launches using established Advanced Product Quality Planning (APQP) project management practices and MS Project.
- Leads cross-functional teams of resources, drawing from other functional areas, to ensure on-time delivery and a flawless launch to production utilizing ARAS and APQP best-practices.
- Provides leadership to comply with, and maintains documentation in accordance with Freudenberg Medical Quality System Requirements (QSR), FDA cGMP, internal procedures, customer requirements and notified body requirements.
- Measures, reports, and continuously improves performance metrics (KPIs) of the product development and launch process.
- Assists in development of design standards, cost standards and pricing standards to expedite and provide input for continuous improvement of the quote process
- Develop accurate and timely manufacturing costs in response to customer or internal inquiries; create new work center costs as needed for cost calculations.
- Responsible to support new product cost-estimating and team feasibility reviews for new business opportunities for molding in addition to large scale sustaining projects.
- Reviews, recommends, and directs the “make or buy” decision process.
- Support and develop validation protocols and reports (IQ/OQ/PQ) and provide objective evidence that equipment, processes, test methods and product meet requirements and are complaint with applicable regulations.
- Maintains adherence to Company policies, safety/ergonomic standards and good housekeeping practices
- Bachelor’s degree in a related technical field such as Mechanical Engineering, Plastics or Medical Engineering preferred.
- PMP Certification in Project Management and APICS certification
- 5 years minimum of related experience in a regulated manufacturing environment, preferably medical or healthcare products in an engineering role.
- 2 years minimum Project management experience in a manufacturing environment utilizing injection molding methods
- Demonstrated experience providing leadership and managing multiple projects of medium complexity
- Working knowledge of ISO-13485 and FDA cGMP regulations
- Working knowledge of engineering terminology, injection molding processes, tooling and validation protocols.
- Working knowledge of work centers, cost structure, and basic industrial engineering practices.
- Strong interpersonal, oral and written communication skills with the ability to effectively communicate with all levels of the organization, customers and suppliers
- Lean Systems or Six-Sigma Green Belt Certification Preferred
- Strong business and economic acumen
- Prefer experience using SAP software and prior experience in a product cost-estimating role for molding.