| Immediate Interviews for below mentioned client requirement. at Grand Rapids, Michigan, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=1815956&uid= From: Nora West, W3Global [email protected] Reply to: [email protected] Hello, Immediate Interviews for below mentioned client requirement. PACKAGING ENGINEER BOULDER, CO (ONSITE) Job Description - Top Skills needed: Med Device experience, PM skills, ISO 11607 experience. Responsibilities : may include the following and other duties may be assigned. Designs, develops, and tests a wide variety of containers used for the protection, display, and handling of products. Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering. Designs package exteriors considering such factors as product identification, sales appeal, aesthetic quality, printing and production techniques. Responsibilities may include documentation management and/or coordination of Good Manufacturing Practices (GMPs), and may support prototype line development in manufacturing facilities/plants. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience. LEAD AUDITOR PORTAGE, MI OR MAHWAH, NJ (ONSITE) Job Description & Skill Requirement: 1. Require Lead Auditor for ISO 9001:201 / 13485:2016 certification. 2. Shall have good written & communication skills. 3. Should be proficient is writing audit reports and detail oriented. 4. Be able to travel to Supplier site for audits. 5. Shall be well versed with audit planning, execution and risk assessment. 6. Should have knowledge of regulatory compliance (FDA, EUMDR) 7. Good oral & written communication skills QUALITY/MANUFACTURING ENGINEER MEDTRONIC NORTH HAVEN, CT (ONSITE) Responsibilities: - Develop and execute validation and verification protocols (IQ, OQ, PQ) to ensure processes and products meet specified requirements. - Prepare and maintain documentation required for regulatory submissions and audits, such as Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR). Experience: - Medical device industry experience - Minimum 2 years of experience in Project management - Strong communication skills - Strong problem-solving skills - Familiarity with software tools like Microsoft Office Suite Qualification: BE/BS - Mechanical Engineering SYSTEM QE Lafayette, CO (Onsite) '-Strong background in New Product Development (NPD) Systems Engineering, quality assurance, and regulatory compliance within the medical device industry. Lead and mentor teams in the development, implementation, and maintenance of quality assurance processes and standards. Collaborate with cross-functional teams, including R&D, manufacturing, NPD and regulatory affairs, to define and implement systems engineering processes that ensure product quality and compliance throughout the product lifecycle. Conduct risk assessments and manage risk mitigation activities in accordance with ISO 14971 and other applicable standards. Ensure compliance with all relevant regulatory requirements, including FDA, ISO, and other international standards, and participate in regulatory audits and inspections. Oversee validation and verification activities, including the development of test plans, protocols, and reports to ensure that products meet specified requirements. Ensure thorough and accurate documentation of quality assurance activities, including test results, risk assessments, and compliance reports. Define and manage systems requirements to ensure clarity, completeness, and testability. Collaborate with the system engineering team to define, refine, and manage system level requirements to ensure alignment with customer needs, clarity, completeness and testability. Oversee the requirements management process to ensure traceability and compliance. Responsible for verifying all design requirements are present and appropriately incorporated int risk management documentation. Develop and maintain critical to quality (CTQ) matrices to identify key product characteristics and ensure they meet customer needs and regulatory requirements ensuring traceability between them. Lead project teams in the testing of Clinician requirements of devices and products. Including development of protocols, reports and execution of the Design Validations. Develop and manage risk management plans and reports, and conduct regular risk reviews. Collaborate with the system engineering team to define thorough hazard analysis to identify potential risks and mitigate them effectively. Conduct Failure Modes and Effects Analysis (FMEAs) to systematically evaluate potential failure modes and their impacts in collaboration with project teams. Analyze and review product complaints to predict and prevent future issues. Collaborate with the system engineering team to define detailed risk analysis to ensure all potential risks are identified and mitigated. Ensure product security measures are implemented and maintained to protect against potential vulnerabilities. Develop and manage post-market surveillance plans to monitor product performance and safety in the field. Maintain and curate risk logs to ensure accurate and up-to-date risk documentation. Qualification: Any Engineering stream MANUFACTURING ENGINEER (495719) NORTH HAVEN, CT MEDTRONIC EX MEDTRONIC EXPERIENCE IS MANDATORY Collaborate with Quality Engineering to provide manufacturing support. Responsible for providing manufacturing engineering support to specific projects including change analysis, risk analysis, and manufacturing readiness. Should be experienced in conducting Time Study for various assembly line Should be experienced in Medical device manufacturing assembly lines Troubleshoot and resolve issues relating to the safety, efficacy, quality, cost, or delivery of components and finished devices. Need to conduct qualification, verification, and validation activities to produce medical devices. Need to be responsible for completing engineering work and contribute to new product development teams and product support, typically including the following activities: technology development, test of materials or products, preparation of specifications, six sigma, process studies, process improvements, and report preparation. Need to design, procure, and fabricate tooling and fixtures. Design, document, and improve manufacturing processes and operations that control the safety and efficacy of finished devices. Train, develop, and/or provide work direction to operators and technicians. Participate on cross-functional project teams. Coordinate, manage, and document project work and progress, and recommend appropriate revisions. Participate in design control efforts related to risk analysis (failure mode and effect analysis) & design reviews. Work with CFT teams in troubleshooting problems on the production floor. Need to identify and implement process/product improvement alternatives to increase/optimize yield, efficiency, throughput, and/or performance. Design, develop, testing, and validate equipment and processes; analyze and interpret process models and recommend process improvements. Qualification: BS Degree in Packaging Science, Mechanical Engineering or Equivalent/MS Engineering Min 3 yrs. Applicable Experience in packaging engineering, medical devices, pharmaceutical or related industry preferred. Broad knowledge of Mechanical/Manufacturing Engineering. Job Title - Manufacturing Engineer Location - Grand Rapids, MI (Onsite) Job Description & Skill Requirement: Experience working with equipment suppliers Experience in supporting machine builders with kick off and design Experience with Semi-automated and automated equipment Experience with process development in various different processing including but not limited to o Joining technologies / Dispensing / Cannula tipping / Pad printing Experience working on print review and working with design on print updates Experience working in QMS and ERP systems Experience with IQ/OQ/PQ/TMV preferred Worked with cross functional teams Collaborate with Quality Engineering to provide manufacturing support. Responsible for providing manufacturing engineering support to specific projects including change analysis, risk analysis, and manufacturing readiness. Should be experienced in Medical device manufacturing assembly lines Troubleshoot and resolve issues relating to the safety, efficacy, quality, cost, or delivery of components and finished devices. Need to conduct qualification, verification, and validation activities to produce medical devices. Need to be responsible for completing engineering work and contribute to new product development teams and product support, typically including the following activities: technology development, test of materials or products, preparation of specifications, six sigma, process studies, process improvements, and report preparation. Participate on cross-functional project teams. Coordinate, manage, and document project work and progress, and recommend appropriate revisions. Work with CFT teams in troubleshooting problems on the production floor. Qualification: BS Degree in Packaging Science, Mechanical Engineering or Equivalent/MS Engineering Job Title - Quality Engineer Location - North Haven, CT (Onsite) EX MEDTRONIC EXPERIENCE MANDATORY Contribute to continuous improvements in overall product cost and quality. Participate in DFM / DFA activities assuring that packaging/production processes and equipment are taken into consideration. Collaborate with Quality Engineering to provide manufacturing support. Create standardized work and process maps that result in an optimized production system and extended value stream. Support line validation / qualification activities for including IQ, OQ , MSA and PQ. Perform root Cause Analysis (RCA), NCR and CAPA responses. Need to conduct qualification, verification, and validation activities to produce medical devices. Work with CFT teams in troubleshooting problems on the production floor. Design, develop, testing, and validate equipment and processes; analyze and interpret process models and recommend process improvements. Drive the execution of various validation and PFMEA activities as per the project plan Application of statistical and analytical methods such as SPC, SQC and DOE. Contributor to the Capital Expense Request (CER) process, specify cost for Packaging/Labeling/ sealing equipment with consideration to product standard cost targets and capacity demands. Provide detailed engineering analysis and documentation in the management of material disposition, process updates, NCR's and CAPA. Execute Site acceptance test and Factory acceptance test based on North Haven Execute Validation Gap analysis of various product families based in Medtronic Plan and initiate CDPs associated with the various validation activities Co-ordination with stakeholders Provide detailed engineering analysis and documentation in the management of material disposition, process updates, NCR's and CAPA. Qualification: BS Degree in Packaging Science, Mechanical Engineering or Equivalent/MS Engineering Min 3 yrs. Applicable Experience in packaging engineering, medical devices, pharmaceutical or related industry preferred. Broad knowledge of Mechanical/Manufacturing Engineering. C&A ENGINEER BRANCHBURG, NJ (ONSITE) Job Description & Skill Requirement: 7-10 years of PLC programming experience (Allen-Bradley Logix) 5 years of HMI/SCADA design experience (FactoryTalk View) Knowledge of common industrial networks (EtherNet/IP) Knowledge of VFDs and common system interfaces Knowledge of Cognex and Keyence Vision systems Experience in IQ/OQ/PQ Validations Medical Industry Experience is added advantage. Ability to read Process & Instrumentation Drawings is a plus. Ability to read electrical diagrams. Ability to read logic diagrams. Ability to diagram using CAD software. Low-voltage electrical design & layout a plus. Strong electrical & mechanical troubleshooting skills. Strong technical writing and communication skills. Team player who can adapt well to engineering standards Qualification: Bachelor or Master Degree in Electrical/Electronics Engineering POWER BI DATA ANALYTICS BRANCHBURG, NJ (ONSITE) $50-55/hr. on C2C Max If you have profiles on Power BI only with little bit know-how of Manufacturing report, Quality Control Reports and dashboards etc, then share profile for same as well. Not necessarily PLC experience is needed. Job Description & Skill Requirement: Good experience in Power BI 7-10 years of PLC programming experience (Allen-Bradley Logix) Experience in integrating Rockwell PLC data with Power BI for Dashboard and Reports Medical Industry Experience is added advantage. Strong technical writing and communication skills. Team player who can adapt well to engineering standards Qualification: Bachelor or master's degree in electrical/Electronics Engineering Keywords: business intelligence rlang microsoft Colorado Connecticut Michigan New Jersey Immediate Interviews for below mentioned client requirement. [email protected] http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=1815956&uid= |
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| 01:15 AM 05-Oct-24 |