Manufacturing Engineer II - villalba - MG STAFFING GROUP

    MG STAFFING GROUP
    MG STAFFING GROUP villalba

    hace 5 horas

    Descripción

    Manufacturing Engineer will support the introduction of new products and manufacturing processes within a regulated medical device environment. The role focuses on equipment validation, process development, and ensuring manufacturing processes comply with regulatory and quality requirements. The engineer will work closely with cross-functional teams to support equipment qualification, process validation activities, and production line implementation.

    Responsibilities:

    • Design and develop manufacturing processes, procedures, and production layouts for assemblies, equipment installation, and material handling.
    • Support new product introduction (NPI) activities including process development and validation.
    • Execute equipment qualification activities (IQ/OQ/PQ) and support process validation lifecycle.
    • Develop and execute validation protocols and reports for manufacturing equipment and processes.
    • Support process characterization, operational qualification, and performance qualification activities.
    • Develop and update Standard Operating Procedures (SOPs) and manufacturing documentation.
    • Support change control processes in compliance with medical device regulations.
    • Assist in statistical analysis and design of experiments (DOE) using tools such as Minitab.
    • Provide line support during special builds and production activities.
    • Investigate manufacturing issues, implement corrective actions, and ensure product quality.
    • Collaborate with engineering teams to optimize manufacturing processes and equipment utilization.
    • Ensure manufacturing processes comply with regulatory and quality system requirements.

    *Other duties may be assigned*



    Requirements

    Minimum 3 to10 years of relevant engineering experience in manufacturing, validation, or process engineering within a regulated industry.

    Bachelor's Degree in Engineering completed.

    Top 3 Candidate Experience Requirements:

    1. Equipment Qualification (IQ) experience
    2. OQ / PQ or Process Validation experience
    3. Process Validation Lifecycle knowledge (Process Characterization → OQ → PQ)
    4. DOE (preferred using Minitab)

    Technical Skills (Must Have):

    • Experience performing Equipment Qualification (IQ).
    • Experience with Operational Qualification (OQ) and Performance Qualification (PQ).
    • Knowledge of the Process Validation Lifecycle (process characterization → OQ → PQ).
    • Experience supporting process validation within a regulated environment.

     Preferred Technical Skills:

    • Experience with Design of Experiments (DOE) using Minitab.
    • Experience with Injection Molding Processes.
    • Experience in Process Development and Documentation.
    • Experience with Equipment Validation.
    • Experience supporting Special Builds and Manufacturing Line Support.

     Additional Skills:

    • Computer System Validation (CSV)
    • SOP Development
    • Change Control in Medical Devices
    • Experience with MES systems
    • Documentation management within regulated industries
    *Willing to work 100% On-site in Villalba,PR*.

  • Trabajar en empresa

    Prin. Manufacturing Engineer

    Solo para miembros registrados

    We are searching for a Principal Engineer who will be instrumental in maintaining and supporting the level of new product and process design and development expertise at the Villalba site. · ...

    Villalba

    hace 2 semanas

  • Trabajar en empresa

    Manufacturing Engineer- 146

    Solo para miembros registrados

    +Job Summary · This is a manufacturing engineer position that involves designing and developing manufacturing processes, procedures, and production layouts for assemblies and equipment installation. · ...

    Villalba

    hace 2 semanas

  • Trabajar en empresa

    Manufacturing Engineer II

    Solo para miembros registrados

    Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join ...

    Villalba

    hace 1 semana

  • Trabajar en empresa

    Manufacturing Engineer II

    MG STAFFING GROUP

    Design manufacturing processes, procedures, and production layouts for assemblies, equipment installation, machining, processing, and material handling. · Design and optimize equipment and machine arrangements within plant facilities to improve productivity and workflow efficienc ...

    villalba

    hace 1 día

  • Trabajar en empresa

    Manufacturing Engineer II

    Solo para miembros registrados

    Join our innovative company at Cencora and help us improve the lives of people and animals everywhere. · ...

    Villalba

    hace 1 semana

  • Trabajar en empresa

    Manufacturing Engineer II

    Solo para miembros registrados

    Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join ...

    Villalba

    hace 1 semana

  • Trabajar en empresa

    Manufacturing Engineer II - 134

    Solo para miembros registrados

    We are a Service Provider company that integrates Engineering, Construction,Maintenance and Specialized Technical services. · ...

    Villalba

    hace 1 mes

  • Trabajar en empresa

    Manufacturing Engineer II - 126

    Solo para miembros registrados

    + Manufacturing Engineer II · + Bachelor's Degree in Engineering, 2 years experience in Medical Devices Industry. · Spanish English · + Investigation Root Cause Analysis Skills · Process Validation Equipment IQ Computer software validation knowledge Technical writing · ...

    Villalba

    hace 3 semanas

  • Trabajar en empresa

    Sr. Prin Manufacturing Engineer

    Solo para miembros registrados

    We are searching for a Sr Principal Engineer who will be instrumental in maintaining and supporting the level of new product and process design and development expertise at the Villalba site. · ...

    Villalba

    hace 2 semanas

  • Trabajar en empresa

    jt437 - manufacturing engineer ii

    Solo para miembros registrados

    In this role, you'll work with a highly enthusiastic team, contributing in a world-class manufacturing industry. · ...

    Villalba

    hace 1 mes

  • Trabajar en empresa

    jt729 - manufacturing engineer ii

    Solo para miembros registrados

    This is a Manufacturing Engineer role working with a highly enthusiastic team in the manufacturing industry in Puerto Rico & USA. · ...

    Villalba

    hace 2 semanas

  • Trabajar en empresa

    jt009 - manufacturing engineer ii

    Solo para miembros registrados

    a leader in the pharmaceutical, biotech, medical devices, · and manufacturing industry is looking for a talented highly motivated and enthusiastic to join our team. · Must have knowledge in Process Validation Equipment IQ and Computer software validation. · ...

    Villalba

    hace 3 semanas

  • Trabajar en empresa

    Quality Engineer

    Solo para miembros registrados

    The Quality Engineer will support product transfer activities from development through commercial release, · ensuring manufacturing processes and quality systems are compliant and ready to support commercial production in a regulated medical device environment.Bachelor's Degree i ...

    Villalba

    hace 3 semanas

  • Trabajar en empresa

    Supplier Quality Engineer I - 109

    Solo para miembros registrados

    We are a Service Provider company different from the rest. We integrate Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island (and in the US as well). Our company is flexible, family-oriented, and focused on our resources' well-be ...

    Villalba

    hace 1 mes

  • Trabajar en empresa

    Process Validation Engineer - 134

    Solo para miembros registrados

    +Job summary · Design manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing machining and material handling. · +Bachelor's Degree in Engineering. · ...

    Villalba

    hace 1 mes

  • Trabajar en empresa

    jt409 - industrial engineer ii

    Solo para miembros registrados

    · ...

    Villalba

    hace 1 mes

  • Trabajar en empresa

    Process Engineer II

    Solo para miembros registrados

    As a Process Engineer II at Medtronic, you'll lead with purpose and break down barriers to innovation in a more connected and compassionate world. · ...

    Villalba

    hace 1 mes

  • Trabajar en empresa

    Process Engineer II

    Solo para miembros registrados

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. · A Day in the Life · The role of a P ...

    Villalba

    hace 4 días

  • Trabajar en empresa

    Packaging Engineer

    MG STAFFING GROUP

    The Packaging Engineer will be responsible for designing, developing, validating, and optimizing packaging systems to support Product Transfer and New Product Introduction (NPI) initiatives. This role requires hands-on experience working with packaging lines, filling equipment, a ...

    villalba

    hace 13 horas

  • Trabajar en empresa

    Project & Process Optimization Manager- 121

    Solo para miembros registrados

    Job summaryThe Project & Process Optimization Manager is responsible for overseeing and managing the operational aspects of ongoing projects, serving as liaison between project management, project team, and line management. The manager develops and implements process improvements ...

    Villalba

    hace 1 mes

Empleos