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Intellectt Inc
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  • Demand & Supply Chain Planning Analyst 2  

    Intellectt Inc
    - Bergen County
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    Role: Demand & Supply Chain Planning Analyst 2Location: Franklin Lakes... Read More
    Role: Demand & Supply Chain Planning Analyst 2Location: Franklin Lakes, NJ - 4 days onsite. Friday remoteDuration: 03 months, no extensionSkills needed:Utilise SAP GTS (Global Trade Services) system to do sanctioned party list screening.GTS is a module where import and export transactions are conducted.Ideal candidates will have experience with SAP GTS.Looking at BD business partners and comparing them to government denied party lists and determine if any are matching.Need to be curious, investigative and like to do research.Experience with entry level Excel for reporting and analytics. Should be able to do large data and pivot tables and analyze data.Need candidates with background in supply chain. Typically with import and export regulations, customs terminology.Temp to hire possibility for the right candidate.Education & Experience:3-5 years of relevant experience.Bachelor's degree is ideal for temp to hire but Associates will work as well. Read Less
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  • Quality Engineer – Medical Devices & Combination Products  

    Intellectt Inc
    - Lake County
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    Job Description:The Quality Engineer ensures medical devices and combi... Read More
    Job Description:The Quality Engineer ensures medical devices and combination products (e.g., auto-injectors, infusion pumps, biologics, pre-filled syringes, injection-molded disposables) meet global quality standards from development through manufacturing and post-market. Responsible for compliance with ISO 13485, ISO 14971, 21 CFR 820/4, EU MDR, and FDA regulations, including remediation and consent decrees.Responsibilities:Lead design transfer, on-market change management, and supplier/third-party quality (CAPA/SCAR, supplier qualification, TPM).Oversee validation and engineering activities (IQ/OQ/PQ, TMV, DOE, Master Validation Plans).Apply risk management tools (DFMEA/PFMEA) to drive product quality.Mentor teams, support audits/inspections, and implement process improvements.Drive cross-functional projects, QMS remediation, change management, and audit readiness.Qualifications:Bachelor’s in science, engineering, or related field; ASQ certification or advanced degree preferred.5+ years QA experience in medical devices/combination products.Strong project management, problem-solving, and cross-functional leadership skills.Familiarity with infusion pumps, autoinjectors, pre-filled syringes, eyecare or biologics preferred. Read Less
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  • Trade Compliance SPL Screening (Franklin Lakes)  

    Intellectt Inc
    - Bergen County
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    Role: Demand & Supply Chain Planning Analyst 2Location: Franklin Lakes... Read More
    Role: Demand & Supply Chain Planning Analyst 2Location: Franklin Lakes, NJ - 4 days onsite. Friday remoteDuration: 03 months, no extensionSkills needed:Utilise SAP GTS (Global Trade Services) system to do sanctioned party list screening.GTS is a module where import and export transactions are conducted.Ideal candidates will have experience with SAP GTS.Looking at BD business partners and comparing them to government denied party lists and determine if any are matching.Need to be curious, investigative and like to do research.Experience with entry level Excel for reporting and analytics. Should be able to do large data and pivot tables and analyze data.Need candidates with background in supply chain. Typically with import and export regulations, customs terminology.Temp to hire possibility for the right candidate.Education & Experience:3-5 years of relevant experience.Bachelor's degree is ideal for temp to hire but Associates will work as well. Read Less
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  • Mechanical Engineer – (Medical Devices)  

    Intellectt Inc
    - Passaic County
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    Job Summary:We are seeking a highly experienced and innovative Senior... Read More
    Job Summary:We are seeking a highly experienced and innovative Senior Mechanical Engineer to drive the development of advanced electro-pneumatic and mechanical systems. The ideal candidate will apply deep mechanical engineering expertise, lead complex design and re-design projects, and provide technical guidance to cross-functional teams and junior engineers.Key Responsibilities:Apply subject matter expertise in mechanical design, analysis, and system development.Conceive and implement solutions to complex pneumatic, mechanical, and electrical design challenges.Establish design objectives and contribute to writing specifications and comprehensive engineering reports.Review and develop detailed product specifications.Conduct conceptual and detailed design studies using MCAD, SolidWorks, and other engineering tools.Collaborate with multidisciplinary teams throughout the design and development process.Develop prototype hardware in coordination with internal manufacturing and external vendors.Conduct rigorous testing to verify compliance with performance, safety, regulatory, and environmental requirements.Apply Design for Manufacturability and Assembly (DFM&A) principles to product designs.Generate and maintain detailed engineering documentation supporting the product development lifecycle.Serve as a technical mentor and project lead, providing guidance to junior engineers and managing small to medium-sized projects.Technical Expertise / Skills:Advanced proficiency in SolidWorks CAD, MCAD/CAE tools, Microsoft Office Suite, Microsoft Visio, Microsoft Project, and Adobe Acrobat.Strong background in materials and manufacturing methods, including:Injection moldingPlastic extrusionMetal casting, stamping, and machiningAdditive manufacturingFamiliarity with ANSI/ISO dimensioning and drafting standards, including GD&T.Experience with mechanical testing, measurement equipment, and statistical analysis of test data.Understanding of regulatory requirements and document control systems, especially within medical device environments.Knowledge of FDA, IEC, and UL standards for medical electronic equipment.Capable of thermal, structural, and vibration analysis.Skilled in mechanism design, analytical reasoning, and creative problem-solving.Ability to operate lab and shop equipment (e.g., drill press, lathe, milling machine, oscilloscopes, DVMs, environmental chambers).Experience with database and document management systems.Minimum Qualifications:BSME or MSME required.Minimum of 10 years of progressive experience in mechanical design and product development.Proven experience leading technical sub-projects and mentoring engineers.Strong interpersonal, verbal, and written communication skills. Read Less
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  • Process Engineering Manager  

    Intellectt Inc
    - Hillsborough County
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    Title: Process Engineering ManagerLocation: Hudson, NHFull Time with B... Read More
    Title: Process Engineering ManagerLocation: Hudson, NHFull Time with BenefitsEssential Duties and Responsibilities:Responsible for providing engineering team leadership including development, training, and succession planning.Manage the daily activities of the maintenance team to proactively maintain machines, plan and execute preventive maintenance and coordinate projects related to maintaining the facility.Manage the development of document control to include work instructions, manufacturing drawings, technical specifications, performance data and process checklists necessary to manufacture the product.Develop and maintain standard operating procedures (SOP’s) and set process parameters.Manage the design fixtures to be used in manufacturing and quality.Develop the quality procedures necessary to validate the product and necessary fixtures, tools or test jigs that may be needed for the manufacturing and quality process.Perform statistical process studies.Perform equipment and process validations.Design of experiments to identify and reduce process variation.Requirements:Master’s degree in engineering 7+ Years of experience in a medical component Industry3+ Years Manufacturing Process Engineering experienceKnowledge of ISO 9001 and ISO 13485,Strong documentation and technical writing skills Read Less
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  • Quality Engineer  

    Intellectt Inc
    - Lake County
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    Hello JobseekersIntellectt Inc is hiring for Quality Engineer for its... Read More
    Hello JobseekersIntellectt Inc is hiring for Quality Engineer for its fortune Medical Device client. Below are the details:Job Title: Quality EngineerLocation: North Chicago ILDuration: 6 months contract (extension possibility)No BenefitsJob Description:Responsible for representing QA on cross-functional teams and executing Quality System requirements to ensure products are properly transferred from development to manufacturing and maintained on market.Responsible for assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide.Products include medical devices and combination products, such as infusion pumps, enteral and sub-cutaneous tubing, Pre-filled Syringes, Autoinjectors, Eyecare Products, Aesthetics Devices, etc.Responsibilities* Primary driver for the quality and compliance aspects of Design transfer and on-market change management.* Serve as the primary quality lead for design transfer activities to enable product launch, including transfers both within and outside of client.* Mentor/lead product team members through the design transfer process providing guidance to assure optimal approach.* Own change plans to manage on-market design changes, collaborate with cross-functional team for impact assessments, define and execute action plans, and monitor to ensure timely closure.* Ensure design control documentation (Traceability/Linkages) & design change control requirements are met.* Identify gaps/improvement opportunities within the Design History File and Risk Management and track to closure.* Assist 3rd party suppliers during change management process, including change management strategies.* Identify gaps in existing processes as well as the need for new processes. Lead cross-functional teams for solution development and implementation.* Support the preparation of regulatory inspections and internal audits and represent QA in inspections and audits as SME.* Participate in the development of global Product Quality Assurance strategy to support device and combination products produced at * plants as well as contract manufacturing and supplier facilities. Implements agreed strategy.* Make recommendations for key decisions on product quality, compliance and regulatory conformance issues.* Establish and maintain relationships and open communication with suppliers, contract manufacturers, * plants, affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an in-depth understanding of the quality, compliance, and resource needs at each site and provide guidance on quality concerns.* Initiate assignments independently. Actively lead and participate on development and process improvement teams. Anticipate/resolve quality issues and take preventative actions.* Actively monitor effectiveness of processes and quality of project work, propose and execute quality/process improvements. Write/review policies/processes/procedures and related documents.* Conduct, lead, or participate in investigations and review boards for Change Plans, CAPAs, NCRs, Observations, etc.Qualifications* Bachelor’s degree in science, engineering, or other technical areas; or equivalent job experience required. Advanced degree preferred; ASQ certification preferred (CQA, CQE, SSBB, etc.)*Relevant experience in the medical device industry; at least 5+ years in Quality Assurance experience required.* Working knowledge of ISO 13485, ISO 14971, 21 CFR 4, 21 CFR 820, EU Regulation 93/42/EEC (MDD) & 2017/745 (MDR).* Working knowledge of international standards and regulations applicable to medical devices and combination products.* Experience with medical devices and/or combination products such as infusion pumps, PFS, Autoinjector, or Eyecare Products preferred.* Ability to apply practical and technical problem solving to quality system and product improvements.* Excellent interpersonal skills, including ability to work effectively cross-culturally and cross-functionally.* Proven ability to effectively lead cross-functional teams and to influence where direct reporting line relationships do not exist.* Capable of developing matrix relationships with key colleagues in other functional areas and divisions; Recognizes other colleagues' areas of expertise and utilizes them effectively to achieve team objectives.* Champions high quality deliverables, innovation, and appropriate risk-based decision making; Ability to understand the sensitivities within the *’s environment.* Excellent project management and interpersonal skills.* Adaptable to changes in work environment.* Ability to work in a fast-paced environment.📩 Apply today to learn more!

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  • Automation Engineer-PLC  

    Intellectt Inc
    - Henrico County
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    Job SummaryReporting to the Director, Business Excellence the Global A... Read More
    Job SummaryReporting to the Director, Business Excellence the Global Automation Engineer Leads the global development,standardization, and implementation of automation systems and best practices across Critical Power manufacturingsites. Acts as a technical liaison and mentor, driving consistency, efficiency, and innovation in the design and deploymentof automation solutions for power distribution equipment and related manufacturing processes.What a typical day looks like:• Develop and standardize global automation best practices, ensuring alignment across all Critical Power sites.• Act as a global liaison between regional teams, engineering, and leadership to ensure consistentimplementation of automation strategies.• Provide technical leadership and mentorship to regional engineers• Design, engineer, and commission PLC, HMI, and SCADA-based automation systems for manufacturing andtesting of power distribution equipment, including the development and modification of moderately complextooling, machinery, and processes.• Collaborate with electrical and mechanical engineering teams to ensure seamless integration of automationinto product designs• Integrate automation systems with MES, historian, and enterprise platforms (e.g., SAP, Power BI)• Ensure compliance with global electrical and safety standards (e.g., NFPA 70E, IEC, UL, CE)• Establish technical manuals, drawings, models, training documentation, preventative maintenance plans andtroubleshooting guides for automated equipment and automated processes.• Collaborates and offers input to planning, building, and maintaining the Automation framework and associatedprocesses for new products.• Identifies and drives change to ensure automation effectiveness of existing processes.• Demonstrates and thorough understanding of customer requirements, offer suggestions and ideas on how bestto deliver automation solutions.The experience we’re looking to add to our team,• Bachelor’s degree in Electrical Engineering, Automation Engineering, Mechatronics, or a related technical field.• Minimum of 8 years of experience in industrial automation, with at least 3 years in a senior or global role.• Proven experience in designing and commissioning automation systems for manufacturing environments,preferably in power distribution equipment or data center infrastructure.• Proficiency in PLC programming (Allen-Bradley, Siemens, Schneider Electric).• Experience with SCADA/HMI platforms (Ignition, Wonderware, GE Cimplicity).• Strong understanding of power monitoring and control systems (e.g., Schneider PME, Eaton Foreseer).• Familiarity with Visual Basic for legacy system support and custom tool development.• Knowledge of robotic welding and automated painting systems.• Experience with industrial communication protocols: Modbus, OPC UA, DNP3, SNMP · Electrical design tools(AutoCAD Electrical, EPLAN) and power system modeling (ETAP, SKM).• Data acquisition and visualization tools (OSIsoft PI, Power BI, SQL).Here are a few of our preferred experiences,• Master’s degree in Engineering, Industrial Automation, or related discipline• Familiarity with global standards (e.g., IEC, UL, CE) and compliance requirements• Certifications such as:o Certified Automation Professional (CAP) – ISAo Professional Engineer (PE) licenseo TÜV Functional Safety Engineer (for safety-critical systems) Read Less
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  • Electrical Test Technician  

    Intellectt Inc
    - Henrico County
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    The Electrical Test Technician 1 is responsible for the testing & trou... Read More
    The Electrical Test Technician 1 is responsible for the testing & troubleshooting of Power Distribution Equipment and related components while ensuring quality workmanship, reliability, & maintaining a safe workplace in all Test areas.ESSENTIAL DUTIES AND RESPONSIBILITIES:• Test & verify the performance/function of power distribution equipment and assemblies, using multi-meters,current meters, HI‐POT Testers, Phase Rotation Meters, and other testing equipment.• Perform Factory Testing on PDUs, Switchgear, STS, Databar product line, and Injection Testing.• Read blueprints, schematics, diagrams, or technical orders to determine methods and sequences of assembly,ensuring conformance to product specifications.• Read inspection and testing procedures, adjustment methods, and certification processes to ensure proper testprocedures are followed.• Obtain and accurately record data obtained during testing using a computer and several types of programs notlimited to Modbus Poll, Adobe Acrobat, Word, Excel, various web interfaces, and other specialized programs.• Complete inspection of all electrical equipment coming into the Test areas.• Completion of technical reports and Factory Acceptance Tests.• Verify and install revolving cable layouts for different jobs.• Make necessary repairs and/or refer test issues to the Supervisor for further diagnosis.• Collaborate with other departments to ensure company product specifications are being followed or to assistwith other manufacturing needs.• Report defective materials or questionable conditions to the Test Department Supervisor.• Maintain a safe and clean working environment within all Test areas.REQUIREMENTS:• High School Education or GED with 1 - 2 years practical work experience testing Low Voltage distributionsystems; Two‐year technical degree in electronics, engineering, or related field preferred.-OR-Military experience and training in electronics, electricity, engineering, or related fields.• Experience with L/V Switchgear, Power Distribution Units, Remote Power Panels, Static Switches, & PoweredBusway Systems preferred. Data Center and/or equivalent mission-critical systems experience preferred.• Knowledge and understanding of safety protocols & electrical codes such as NFPA 70E, NEC Code, UL & IEC.• Knowledge and understanding of 3‐Phase Power, DC Power, Electrical Power Generation, and AC/DC powerdistribution.• Understanding the hazardous nature of the department and ability to recognize dangerous conditions beforetesting is performed.• Knowledge and understanding of troubleshooting to the circuit board & component level.• Ability to use a wide variety of hand tools and test equipment.• Ability to read schematics and drawings.• Ability to operate and accurately use a computer for data logging.• Ability to maintain a tactful, orderly working relationship with other Test Team members.• Ability to read and write English with excellent communication skills, follow verbal instructions accurately, andunderstand and apply mathematic equations and practices.• Ability to work overtime & weekends as needed. Read Less
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  • Regulatory Affairs Specialist  

    Intellectt Inc
    - Lake County
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    Description:This section focuses on the main purpose of the job in one... Read More
    Description:This section focuses on the main purpose of the job in one to four sentences.Under limited supervision responsible for the implementation of regulatory strategies, and resolution of issues pertaining to documents/ packages for regulatory submissions.Produces and evaluates technical and scientific data necessary for regulatory submissions. Assists in the implementation and delivery of new or upgraded systems and processes in support of companies products.This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work.The incumbent will perform other duties assigned:- Document all system related issues, and identify resolutions- Document complex processes and create and manage documentation related to validated systems- Participate in identifying solution to meet requirements for systems- Participate in system upgrades to assure integrity of data is maintained- Assure adequate access and functioning of system tools and version upgrades- Provides expertise in ongoing maintenance of electronic record receipt and submission to regulatory authorities- Participate as an active team member and provide expertise to project teams as required- May verify the maintenance of support systems, libraries and dictionaries- Maintain awareness of regulatory requirements and evaluate potential impact to company To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.List knowledge, skills, and/or abilities required.Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.- Detail oriented - Technical system skills (e.g. word processing, spreadsheets, databases, online research) - Written and verbal communication skills - Knowledge of applicable regulations - Excellent organizational skills and ability to support multiple projects - Ability to contribute to multiple projects from an operations perspective- Work independently with minimal direct supervision- Strong negotiation and collaboration skills- Manage multiple projects and deadlines- Ability to identify compliance risks and resolve or escalate when necessary- Experience in addressing complex problems or processes Include the education and experience that is necessary to perform the job satisfactorily.Bachelors Degree or country equivalent with a minimum of 5 years in a regulated environment. Scientific or related discipline would be an advantage. Read Less
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  • Manufacturing Process Engineer  

    Intellectt Inc
    - Hillsborough County
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    Job Title: Manufacturing Process EngineerLocation: New HampshireDurati... Read More
    Job Title: Manufacturing Process EngineerLocation: New HampshireDuration: Full TimeNote: Only U.S. citizens or Green Card holders are eligibleAbout the Role:The Manufacturing Process Engineer (MPE) supports manufacturing operations by developing, improving, and validating processes to ensure quality, efficiency, and compliance with ISO and FDA standards. This role involves hands-on work with machining processes, cross-functional collaboration, and continuous improvement initiatives.Key Responsibilities:Develop and optimize manufacturing processes, work instructions, and SOPs.Design fixtures, tooling, and validation procedures for production and quality assurance.Conduct process validations, DOE studies, and statistical process control (SPC) analysis.Identify and implement process improvements to reduce waste and improve efficiency.Support new product introductions and ensure products meet customer requirements.Lead root cause analysis and corrective actions for production issues.Train manufacturing personnel on procedures and process controls.Manage project schedules, documentation, and communication with customers and internal teams.Ensure compliance with ISO and FDA regulations.Qualifications:Bachelor’s degree in Mechanical, Industrial, or related Engineering field.3–5 years of experience in manufacturing process engineering.CNC machining experience required.Proficiency in SolidWorks, SPC tools, and MS Office Suite.Strong understanding of GD&T and blueprint interpretation.Experience in ISO/FDA-regulated manufacturing preferred.Excellent problem-solving, communication, and project management skills.High attention to detail, urgency, and teamwork.

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