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Product Development Engineer

Mg Staffing Group
  • Juncos, Juncos
    30+ days ago

    Job Description

    The Product Development Engineer supports the design, development, and continuous improvement of medical device products by implementing engineering changes, maintaining design documentation, and ensuring compliance with quality and regulatory requirements. This role collaborates with cross-functional teams including Engineering, Manufacturing, Quality, Planning, and Materials to develop design solutions that improve product performance, manufacturability, and operational efficiency.

    Responsibilities

    • Support product design, development, and engineering change activities throughout the product lifecycle.
    • Prepare and maintain engineering documentation, specifications, and technical records in accordance with company quality standards.
    • Initiate and process engineering change documentation, including:
      • Product Change Notices (PCH)
      • Revision Change Notices (RCH)
      • Design Change Notices (DCH)
      • Quality Change Notices (QCH)
      • Manufacturing Change Specifications (MCS)
    • Execute engineering changes using Agile MAP, SAP, and Design Control systems.
    • Review product development requirements to ensure compatibility with manufacturing processes and product design outputs.
    • Collaborate with Product Development, Manufacturing, Quality, Materials, Tooling, and Planning teams to ensure design feasibility and manufacturability.
    • Modify existing product designs and components to improve product functionality, manufacturing efficiency, and field performance.
    • Develop and maintain CAD models, drawings, and engineering documentation using approved design software.
    • Coordinate design requirements with cross-functional teams to optimize manufacturing processes, material availability, tooling, and contractual requirements.
    • Ensure engineering documentation and product development activities comply with applicable quality systems and regulatory standards.
    • Identify opportunities for process improvements and recommend solutions to enhance engineering efficiency and product quality.
    • Participate in technical projects and support new product development initiatives.
    • Provide technical guidance and mentoring to junior engineers when required.
    • Support project execution while meeting timelines, quality objectives, and business priorities.


    Requirements

    Education

    • Bachelor's Degree in Mechanical Engineering, Biomedical Engineering, Industrial Engineering, or a related Engineering discipline.
    • Advanced degree is a plus.

    Experience

    • Minimum of 2 years of engineering experience in product development, design engineering, or manufacturing engineering.
    • Experience in regulated industries such as Medical Device, Pharmaceutical, or Life Sciences preferred.
    • Experience managing engineering changes and design documentation.

    Required Technical Skills

    • Agile MAP / Product Lifecycle Management (PLM)
    • SAP
    • Design Control Systems
    • CAD software (SolidWorks, CATIA, Creo/ProEngineer, Siemens NX, AutoCAD, or similar)
    • Engineering documentation and technical specifications
    • Product Design & Development
    • Engineering Change Management
    • Design for Manufacturability (DFM)
    • Quality Systems and Design Controls

    Preferred Knowledge

    • Product Lifecycle Management (PLM)
    • Medical Device Design Controls
    • Engineering Change Order (ECO) processes
    • Manufacturing processes
    • Root Cause Analysis
    • Process Improvement
    • Project Management fundamentals
    • Regulatory compliance (FDA, ISO 13485)

    Soft Skills

    • Strong verbal and written communication skills
    • Bilingual (English & Spanish)
    • Excellent analytical and problem-solving skills
    • Strong organizational and documentation abilities
    • Quality-focused mindset
    • Ability to work independently with minimal supervision
    • Cross-functional collaboration and teamwork
    • Ability to manage multiple priorities in a fast-paced environment
    • Leadership, coaching, and mentoring skills
    • Continuous improvement mindset




    Numbers & Facts

    LocationJuncos, Juncos
    Websitehttp://www.medialgroup.com

    Skills

    • Agile PLM / Oracle PLM (Product Lifecycle Management)unmatched
    • Agile Programming Methodologiesunmatched
    • Analysis Skillsunmatched
    • AutoCADunmatched
    • Biologyunmatched
    • Biomedical Engineeringunmatched
    • Biotech and Pharmaceuticalunmatched
    • CAD (Computer-Aided Design) Softwareunmatched
    • CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing)unmatched
    • CATIA CADunmatched
    • Change Managementunmatched
    • Coachingunmatched
    • Communication Skillsunmatched
    • Continuous Improvementunmatched
    • Contract Requirementsunmatched
    • Control Systemsunmatched
    • Creo Elements/Prounmatched
    • Cross-Functionalunmatched
    • Documentationunmatched
    • Engineeringunmatched
    • Engineering Change Managementunmatched
    • Engineering Change Orderunmatched
    • Engineering Managementunmatched
    • English Languageunmatched
    • FDA Requirementsunmatched
    • ISO (International Organization for Standardization)unmatched
    • Industrial Engineeringunmatched
    • Leadershipunmatched
    • Machine Toolunmatched
    • Maintain Complianceunmatched
    • Manufacturingunmatched
    • Manufacturing Designunmatched
    • Manufacturing Engineeringunmatched
    • Manufacturing Requirementsunmatched
    • Manufacturing/Industrial Processesunmatched
    • Mechanical Engineeringunmatched
    • Medical Equipmentunmatched
    • Medical Productsunmatched
    • Mentoringunmatched
    • Multilingualunmatched
    • Multitaskingunmatched
    • Operational Strategyunmatched
    • Organizational Skillsunmatched
    • PTC Creounmatched
    • Performance Managementunmatched
    • Presentation/Verbal Skillsunmatched
    • Problem Solving Skillsunmatched
    • Process Improvementunmatched
    • Product Designunmatched
    • Product Developmentunmatched
    • Product Documentationunmatched
    • Product Engineeringunmatched
    • Product Lifecycleunmatched
    • Product Lifecycle Managementunmatched
    • Product Programsunmatched
    • Product Reviewsunmatched
    • Product Supportunmatched
    • Project Executionunmatched
    • Project/Program Managementunmatched
    • Quality Metricsunmatched
    • Regulationsunmatched
    • Regulatory Complianceunmatched
    • Regulatory Requirementsunmatched
    • Requirements Managementunmatched
    • Root Cause Analysisunmatched
    • SAPunmatched
    • Siemens PLM Software NX (fka UGS NX)unmatched
    • Software Designunmatched
    • SolidWorksunmatched
    • Spanish Languageunmatched
    • Technical Leadershipunmatched
    • Technical Supportunmatched
    • Technical Writingunmatched
    • Technical/Engineering Designunmatched
    • Time Managementunmatched
    • Writing Skillsunmatched

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