Whitridge Associates’ Post

🌟 Top 3 Skills Required for a Packaging Engineer in the Medical Device Industry 🌟 Are you looking to stay ahead in the medical device industry? Understanding the essential skills for key roles is crucial. Here are the top 3 skills every Packaging Engineer must possess: 1. Regulatory Knowledge 📜 Packaging Engineers must have a thorough understanding of regulatory requirements, including ISO 11607, FDA 21 CFR Part 820, and other international guidelines. This knowledge ensures that packaging meets all safety and efficacy standards, keeping products compliant and market-ready. 2. Materials Science Expertise 🔬 A solid grasp of materials science is crucial for selecting appropriate packaging materials. Engineers need to understand polymers, adhesives, and barrier materials to ensure products are protected and maintain sterility throughout their lifecycle. 3. Design and Development Skills 🛠️ Effective design and development skills are essential for creating functional and cost-effective packaging solutions. Proficiency in CAD software, packaging validations, and FMEA helps in anticipating and mitigating potential issues, leading to innovative and efficient packaging. 💡 Want more insights on hiring top talent in the medical device industry? Follow our page for the latest trends, tips, and job opportunities! #MedicalDevices #PackagingEngineering #RegulatoryCompliance #MaterialsScience #DesignAndDevelopment #StaffingSolutions #MedTech #EngineeringExcellence #FollowUs #GroveTechnicalResources #Grove

The best part about my job? You get to understand and help other companies beyond imaginable. Last month I visited multiple medical product manufacturers that basically had the same needs. Fully automating their production processes for product manufacturing. The top 3 reasons for automation I noticed are: 1. Parts become smaller and more difficult to handle manually 2. More work and less people 3. Improve product quality with less scrap   What would be the best reason for you to automate? Let me know in the comments!   #ManufacturingAutomation #ProductionAutomation #Medical #Precision #Engineering #Micro #TakingYouStepsAhead

Interesting #Senior #Engineer Role in California Await You 📢 Apply Now ◼ Role: Senior Engineer ◼Location: Irvine, California ◼Duration:06 Months on W2 Skills Looking For: 🔸 Department: Pilot Quality Engineering 🔹 Supporting up to 25 different programs, with the candidate expected to support 2-3 programs 🔸 Focuses on new product development, clinical trials, process characterization, and improvement, working on both human-use and engineering feasibility study products 🔹 Technical writing experience - ability to write root cause investigations, reports, and technical summaries. 🔸 Teamwork and collaboration 🔹 Test method validations exp; Experience with inspection protocols, reports, and execution of test method validations. 🔸 Minitab for statistical data analysis. 🔹 Quality experience with risk documentation. 🔸 Exp with Keyence platforms, Cognex cameras, Leak testers, Coding machines Day to Day Responsibilities: Testing and inspecting devices; Performing root cause analysis and investigations; Conducting statistical data analysis; Writing root cause investigations, reports, and technical summaries; Collaborating with diverse teams and communicating via Teams, Outlook, and in-person; Executing test method validations, including protocols, reports, and inspections. #QualityEngineering #NewProductDevelopment #ClinicalTrials #ProcessImprovement #TechnicalWriting #RootCauseAnalysis #TeamCollaboration #TestMethodValidation #StatisticalAnalysis #Minitab #RiskDocumentation #Keyence #Cognex #LeakTesting #CodingMachines #DeviceTesting #EngineeringFeasibility #QualityAssurance #InspectionProtocols #EngineeringJobs #h1b #h1jobs

🔍 Attention to detail. Precision is non-negotiable in the Medical Devices sector. As a Quality Engineer, your eagle eye for the minutiae is what ensures products meet stringent regulatory standards and, ultimately, protect patient safety. 🤝 Collaboration is key. You're the bridge between design, manufacturing, and regulatory affairs, ensuring that communication is seamless and that quality is everyone's priority. 🧠 A growth mindset is crucial. The landscape of medical technology is ever-evolving, and staying ahead means embracing continuous learning. Whether it's new regulations or cutting-edge technologies, a great Quality Engineer is always expanding their knowledge base. 📊 Data-driven decision-making. In the world of medical devices, decisions must be backed by solid data. Mastery of statistical analysis tools is not just an asset; it's a necessity for making informed, reliable decisions. 👩🔬 Technical expertise meets regulatory wisdom. A top-notch Quality Engineer in this sector has a deep understanding of engineering principles and combines this with a thorough knowledge of regulatory requirements. It's about ensuring every product not only functions flawlessly but also complies with all necessary guidelines. 🔄 Continuous improvement. The best Quality Engineers are those who not only solve problems but also proactively seek out opportunities for improvement, reducing waste and increasing efficiency without ever compromising on quality. Remember, in the Medical Devices industry, the work of a Quality Engineer is more than a job; it's a commitment to safeguarding lives. #QualityEngineering #MedicalDevices #ContinuousImprovement

🔍 Attention to detail. It's not just a buzzword; it's the bedrock of excellence in the Medical Devices sector. As a Quality Engineer, your eagle eye can mean the difference between a product that changes lives and one that puts them at risk. 🌟 Strong analytical skills are your superpower. You're not just solving problems; you're preventing them before they occur. By understanding complex systems and processes, you ensure that every medical device meets the stringent standards necessary for safe and effective use. 🤝 Collaboration is key. You're the bridge between departments, ensuring that design, production, and regulatory compliance speak the same language of quality. Your ability to work seamlessly with cross-functional teams is what turns innovative concepts into tangible, life-saving tools. 📈 Continuous improvement is your mantra. In an industry where technology and regulations are ever-evolving, your commitment to learning and adapting keeps your company at the forefront of quality. 📜 Regulatory knowledge isn't just about ticking boxes. You navigate the intricate landscape of international standards and regulations like ISO 13485 with ease, ensuring that every product not only meets but exceeds the global benchmarks. Remember, in the realm of Medical Devices, quality is not an act, it's a habit. As a Quality Engineer, you're not just part of the process; you are the guardian of trust in every device that makes its way into the hands of healthcare professionals and patients. #QualityEngineering #MedicalDevices #ContinuousImprovement

📍 Manufacturing Flow of a Medical Device After Design Transfer Design transfer is just the beginning. The real challenge begins with manufacturing. Here’s a streamlined overview: ✅ Validation and Verification  → Ensuring the design meets all requirements. This step includes rigorous testing and compliance checks. 🛠️ Supplier Selection  → Choosing reliable suppliers for materials and components. Quality and consistency are crucial. ♻️ Process Development  →  Creating detailed manufacturing processes. This includes workflow diagrams, SOPs, and training manuals. 🚀 Pilot Production  → Conducting initial runs to identify and fix issues. This step is essential for refining processes. 🏭 Full-scale Production  → Transitioning to large-scale manufacturing. Maintaining quality control is key. Regular audits and inspections ensure standards are met. 📦 Packaging and Labeling  → Ensuring the device is packaged safely. Accurate labeling is vital for compliance and user safety. 🚚 Distribution and Logistics  → Efficiently moving products to market. This involves managing inventory, transportation, and supply chain logistics. What challenges have you faced in manufacturing medical devices? Share your experiences in the comments! Follow for daily insights into tech product development. #MedicalDevices #Manufacturing #Quality #SupplyChain  #SimplifyingInnovation #Unplex

🔍 Exploring the Vital Role of Packaging Engineers in Medical Device Manufacturing 📦💡 Packaging Engineers are the unsung heroes in ensuring the safety, efficacy, and compliance of medical devices. Their meticulous work spans from designing robust packaging solutions to executing critical validation processes that uphold product integrity throughout its lifecycle. Key responsibilities include: ✅ Developing and optimizing packaging designs that meet regulatory standards. ✅ Conducting rigorous testing and validation to ensure packaging durability and sterility. ✅ Collaborating with cross-functional teams to integrate innovative solutions and streamline processes. ✅ Managing risk assessments and implementing corrective actions to enhance packaging quality. ✅ Supporting continuous improvement initiatives to drive efficiency and cost-effectiveness. In the dynamic landscape of medical device manufacturing, Packaging Engineers play a pivotal role in safeguarding patient safety and product quality. Let's recognize their dedication to excellence and innovation in healthcare delivery! 🌟 #PackagingEngineer #MedicalDevices #QualityAssurance #InnovationInHealthcare #MedicalDeviceManufacturing #HealthcareEngineering #RegulatoryCompliance

Hello friends, I have an opening for job Manufacturing Engineer – North Haven, CT. Kindly reach me at #908-615-1717 or #email your #resume at #isha.bhagat@dbsiservices.com. Job Title: Manufacturing Engineer Job Location: North Haven, CT Job Type: Full Time/Contract   Job Description: Perform equipment validation. 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. 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 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 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.  

Design transfer is a critical phase in medical device development. 🔑 Key Documents 1️⃣ Design History File (DHF) Contains all design-related documentation. Demonstrates the design was developed in accordance with the approved design plan. 2️⃣ Device Master Record (DMR) Includes device specifications, production processes, quality assurance, and labeling. Ensures the device is produced consistently. 3️⃣ Risk Management File Documents risk analysis and mitigation strategies. Essential for demonstrating product safety and effectiveness. 4️⃣ Verification and Validation (V&V) Reports Confirm the design meets the requirements. Include test results, protocols, and acceptance criteria. 5️⃣ Design Review Records Minutes and actions from design reviews. Provide evidence of systematic evaluation throughout the design process. 6️⃣ Change Control Records Detail any design changes. Maintain traceability and rationale for modifications. 7️⃣ Supplier and Component Documentation Ensures all parts meet specified requirements. Includes supplier qualifications and component specifications. 8️⃣ Training Records Proof that personnel involved in design transfer are trained. Ensures proper understanding and execution of processes. 📝 Signatures Needed Project Manager → Confirms project completion and readiness for transfer. Quality Assurance (#QA) → Verifies compliance with regulatory and quality standards. Regulatory Affairs (#RA) → Ensures all regulatory requirements are met. Engineering Lead → Validates the technical aspects of the design. Manufacturing Representative → Confirms manufacturability of the design. Risk Management Lead → Verifies risk controls are in place. Ensuring thorough documentation and proper sign-offs mitigates risks and supports compliance. Streamline your design transfer with these essentials for a smooth transition. Follow for daily insights into tech product development. #MedicalDevices #ISO13485 #21CFR820 #QualityAssurance #RegulatoryCompliance #SimplifyingInnovation #Unplex

Medical Device - Important Step in your Design Control process is "Design Verification" and "Design Validation"   Today we are discussing about Design Verification (DV)   Definition : As per FDA states that, “Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.” In other words, do your design outputs meet your design inputs.   ISO 13485 Design and development verification shall be performed in accordance with planned and documented arrangements to ensure that the design and development outputs have met the design and development input requirements.   In this example, design verification checks that your design outputs—such as drawings, specifications, or manufacturing instructions—meet those design inputs.      When Design Verification Required : Following are Major reason need to do DV, but not limited to   New Product Development, Regulatory requirement - regulatory requirements must be met throughout the verification, Standard Requirement – Any standard changes, Spare parts change, Design changes to the product, New Configuration or Specification change to the product, Material Changes.   Phases in DV:   Identifying and Preparing Identify the best approach for conducting verification. Define what you will measure and how you will measure it. You’ll also want to consider the required resources, manpower, and tools for successful verification.   Planning Planning for verification occurs throughout the project life cycle. You’ll develop the test plan, which captures critical milestones. The plan must be updated whenever changes are made to design inputs.   Developing (Protocol release) Product development begins! It’s conducted using the methodology of choice (Scrum, Waterfall, hybrid, etc.). This part of the process also includes writing, test driving, and approving the test cases that will be used for verification.   Executing Test procedures are executed as planned. Any invalid results are documented and reviewed, and either accepted or logged as defects. Defects in the product are resolved and released, and regression testing is performed. A traceability matrix is created to verify that design inputs identified in the verification test plan have been tested and passed.   Reporting Reporting is performed at the end of each phase of verification. Detailed reports include configuration management and release reports, test results by testing type or product version, and issues found during the verification activity. A design verification traceability report shows test results and coverage for the requirements. Finally, reviews are completed and approved after each design verification activity.   In next post we can discuss about sample selection and Non-conformance in DV, DV Protocol each section. #Designverification #Designcontrol #Medicaldevice