Principal Manufacturing Engineer
Aviso de fuente externaen Dew Software
Principal Manufacturing Engineer role supporting process development, validation and manufacturing-readiness projects at a medical device manufacturing site.
Salario
No especificado
Ubicación
Villalba, Puerto Rico
Tipo de empleo
Tiempo completo
Modalidad
No especificado
Principal Manufacturing Engineer
Villalba, Puerto Rico
Descripción del empleo
About the role
Dew Software is seeking an experienced Senior / Principal Manufacturing Process Development Engineer to support manufacturing engineering, process development, validation, and manufacturing-readiness projects at a medical device manufacturing site in Puerto Rico.
The engineer will serve as the onsite technical lead within an onsite-offshore project delivery model, working with Manufacturing, Quality, R&D, Operations, Supply Chain, and Regulatory stakeholders and leveraging IZiel's offshore engineering team for appropriate engineering, validation, analysis, and documentation activities.
Responsibilities
- Serve as the onsite technical lead for manufacturing process development, validation, and manufacturing-readiness projects.
- Work with client stakeholders to understand technical requirements, priorities, timelines, risks, and deliverables.
- Break project scope into work packages and determine which activities should be performed onsite versus offshore.
- Provide technical direction, product and process context, and required inputs to offshore engineers.
- Review offshore deliverables for technical quality, accuracy, and compliance with client requirements.
- Lead onsite activities involving manufacturing equipment, production processes, operators, and site stakeholders.
- Lead manufacturing process development, characterization, optimization, and qualification.
- Plan and execute IQ/OQ/PQ activities.
- Lead or support Test Method Validation (TMV) activities.
- Apply DOE, statistical analysis, and process...
Requirements
- 7+ years of experience.
- Hands-on manufacturing/process engineering experience, with the ability to independently lead onsite technical workstreams and delegate and review appropriate work performed by an offshore engineering team.
Datos clave
- Location: Villalba, PR.
- The role supports manufacturing engineering, process development, validation, and manufacturing-readiness projects.
- The source lists 7+ years of experience.
Preguntas frecuentes
What does this role involve?
It supports manufacturing engineering, process development, validation, and manufacturing-readiness projects at a medical device manufacturing site in Puerto Rico.
What experience is listed?
The listing specifies 7+ years of experience and describes a hands-on manufacturing/process engineer who can lead technical workstreams.
What are some of the responsibilities?
Responsibilities include leading process development and qualification, planning and executing IQ/OQ/PQ activities, and leading or supporting Test Method Validation activities.