Job Overview:We are looking for an experienced Risk Management Owner with expertise in ISO 14971:2019 to oversee risk management processes for medical devices. This role is responsible for conducting Risk Benefit Analysis (RBA), risk assessments, and ensuring compliance with FDA and EU MDR requirements throughout the product lifecycle.Key Responsibilities: Lead risk assessments and gap analyses for medical devices, ensuring proper identification and mitigation of risks.• Conduct Risk Benefit Analysis (RBA) to evaluate trade-offs between risk and product benefits.• Ensure compliance with ISO 14971:2019, FDA, and EU MDR in risk management documentation.• Develop and maintain Risk Management Files (RMF) with clear risk assessments and control measures.• Collaborate with product development, quality, and regulatory teams to integrate risk management into the product lifecycle.• Lead risk control and mitigation strategies to ensure product safety and compliance.• Contribute to regulatory submissions by providing well-documented risk management analyses.• Continuously improve risk management processes, tools, and methodologies.Required Qualifications: 5-8 years of experience in risk management within medical devices or similarly regulated industries.• In-depth experience with ISO 14971:2019 and risk management frameworks.• Strong background in Risk Benefit Analysis (RBA) and risk documentation.• Solid understanding of FDA and EU MDR regulatory requirements.• Strong experience developing risk control strategies and maintaining risk management files.• Proven ability to work cross-functionally with development, quality, and regulatory teams.• Strong verbal and written communication skills in English.Preferred Qualifications: Relevant certifications such as Certified Risk Manager (CRM), Certified Quality Engineer (CQE).• Experience with software risk management in compliance with IEC 62304.• Familiarity with IEC 61508, ISO 14971:2020, and additional safety standards.Personal Attributes: Strong analytical and problem-solving skills, with the ability to assess complex risk scenarios.• Detail-oriented with a focus on compliance and quality.• Excellent communication skills for presenting risk assessments and mitigation strategies.• Ability to work independently and within cross-functional teams.• Capable of managing multiple projects in a fast-paced environment.

Job Overview:We are seeking a System Engineer with 5-8 years of experience in the medical device industry. This role focuses on design controls, traceability, and validation, ensuring that user needs are effectively translated into product requirements and fully documented throughout the product development lifecycle.Key Responsibilities: Develop and implement design control processes in compliance with FDA (21 CFR 820) and ISO 13485.• Ensure traceability between user needs, design inputs, verification, and validation.• Work cross-functionally to ensure design validation aligns with user expectations.• Collaborate on design verification and validation (V&V) activities to confirm product compliance.• Maintain and update Design History Files (DHF) and other required documentation.• Prepare and maintain design control documentation for compliance audits.• Identify process improvement opportunities in design control and traceability methods.Required Qualifications: 5-8 years of experience in system engineering within a regulated environment (preferably medical devices).• Strong background in design controls, traceability, and risk management.• In-depth knowledge of FDA regulations (21 CFR 820), ISO 13485, and related standards.• Experience working in cross-functional teams with strong communication skills in English.Preferred Qualifications: Experience with risk management (ISO 14971) and risk mitigation strategies.• Familiarity with verification and validation (V&V) methodologies.• Proficiency with requirements management and traceability tools.Personal Attributes: Strong analytical and problem-solving skills.• Detail-oriented with a focus on regulatory compliance.• Ability to work independently and collaboratively in a fast-paced environment.

Automate and streamline deployment processes using CI/CD tools. Manage and monitor cloud infrastructure and services. Implement security measures and compliance in DevOps processes. Collaborate with development and operations teams to improve system performance. Troubleshoot and resolve infrastructure and deployment issues. Qualifications Automate and streamline deployment processes using CI/CD tools. Manage and monitor cloud infrastructure and services. Implement security measures and compliance in DevOps processes. Collaborate with development and operations teams to improve system performance. Troubleshoot and resolve infrastructure and deployment issues. Skills Strong knowledge of firewalls, VPNs, IDS/IPS, and security protocols. Experience with SIEM tools (Splunk, QRadar). Proficiency in risk assessment and management. Understanding of compliance standards (ISO, NIST, GDPR). Excellent analytical and problem-solving abilities.

Design, develop, and maintain data pipelines and ETL processes. Build and optimize data architectures for analytics and reporting. Collaborate with data scientists and analysts to support data-driven initiatives. Implement data security and governance best practices. Monitor and troubleshoot data infrastructure and ensure high availability. Qualifications Design, develop, and maintain data pipelines and ETL processes. Build and optimize data architectures for analytics and reporting. Collaborate with data scientists and analysts to support data-driven initiatives. Implement data security and governance best practices. Monitor and troubleshoot data infrastructure and ensure high availability. Skills Proficiency in data engineering tools (Hadoop, Spark, Kafka, etc). Strong SQL and programming skills (Python, Java, etc). Experience with cloud platforms (AWS, Azure, GCP). Knowledge of data modeling, warehousing, and ETL processes. Strong problem-solving and analytical abilities.

Design and develop scalable SaaS applications. Implement cloud-based solutions using AWS, Azure, or similar platforms. Collaborate with product teams to define application requirements. Ensure application security and data protection measures are in place. Optimize performance and maintain the application s reliability. Qualifications Design and develop scalable SaaS applications. Implement cloud-based solutions using AWS, Azure, or similar platforms. Collaborate with product teams to define application requirements. Ensure application security and data protection measures are in place. Optimize performance and maintain the application s reliability. Skills Expertise in SaaS architecture and development. Experience with cloud platforms (AWS, Azure, GCP). Strong programming skills in languages like Python, Java, or Node.js. Understanding of microservices and containerization (Docker, Kubernetes). Knowledge of CI/CD pipelines.

ResponsibilitiesDevelop responsive and interactive web interfaces using HTML, CSS, and JavaScript.Work with designers and backend developers to create seamless user experiences.Optimize web applications for maximum speed and scalability.Debug and troubleshoot UI issues.Job DescriptionDevelop responsive and interactive web interfaces while collaborating with designers and backend developers. The role focuses on optimizing user interfaces for maximum speed and scalability. QualificationsDevelop responsive and interactive web interfaces using HTML, CSS, and JavaScript.Work with designers and backend developers to create seamless user experiences.Optimize web applications for maximum speed and scalability.Debug and troubleshoot UI issues.SkillsProficiency in frontend frameworks like React.js, Angular, or Vue.js.Strong knowledge of HTML, CSS, and JavaScript.Experience with responsive design and cross-browser compatibility.Familiarity with RESTful APIs.

ResponsibilitiesDefine product vision and strategy.Collaborate with cross-functional teams to bring products to market.Conduct market research and analyze user feedback.Manage the product lifecycle from ideation to launch.Job DescriptionManage the development and launch of new products. The role involves defining product roadmaps, working closely with engineering teams, and ensuring products meet market demands. QualificationsDefine product vision and strategy.Collaborate with cross-functional teams to bring products to market.Conduct market research and analyze user feedback.Manage the product lifecycle from ideation to launch.SkillsExcellent communication and leadership skills.Strong analytical and strategic thinking abilities.Ability to manage product roadmaps and backlogs.Experience with product management tools (JIRA, Confluence).

ResponsibilitiesDesign, develop, and maintain data pipelines and ETL processes.Build and optimize data architectures for analytics and reporting.Collaborate with data scientists and analysts to support data-driven initiatives.Implement data security and governance best practices.Monitor and troubleshoot data infrastructure and ensure high availability.QualificationsDesign, develop, and maintain data pipelines and ETL processes.Build and optimize data architectures for analytics and reporting.Collaborate with data scientists and analysts to support data-driven initiatives.Implement data security and governance best practices.Monitor and troubleshoot data infrastructure and ensure high availability.SkillsProficiency in data engineering tools (Hadoop, Spark, Kafka, etc.).Strong SQL and programming skills (Python, Java, etc.).Experience with cloud platforms (AWS, Azure, GCP).Knowledge of data modeling, warehousing, and ETL processes.Strong problem-solving and analytical abilities.

ResponsibilitiesMarket available consultants to potential clients and vendors for contract positions.Build and maintain relationships with vendors, clients, and consultants.Negotiate rates and close deals with clients and vendors.Ensure timely submissions and follow-ups with clients.Maintain accurate documentation of all sales activities in the CRM.QualificationsMarket available consultants to potential clients and vendors for contract positions.Build and maintain relationships with vendors, clients, and consultants.Negotiate rates and close deals with clients and vendors.Ensure timely submissions and follow-ups with clients.Maintain accurate documentation of all sales activities in the CRM.SkillsStrong understanding of the US IT staffing market and visa types (H-1B, GC, OPT, etc.).Excellent negotiation and communication skills.Ability to build and maintain a network of contacts.Proficiency in using ATS and CRM systems.Strong attention to detail and organizational skills.

ResponsibilitiesDesign and develop mobile applications for iOS and Android platforms.Collaborate with UX/UI designers to create user-friendly interfaces.Integrate APIs and third-party services.Perform testing and debugging to ensure high-quality apps.Job DescriptionDesign and develop mobile applications for iOS and Android platforms. The role involves collaborating with UX/UI designers and integrating third-party services. QualificationsDesign and develop mobile applications for iOS and Android platforms.Collaborate with UX/UI designers to create user-friendly interfaces.Integrate APIs and third-party services.Perform testing and debugging to ensure high-quality apps.SkillsProficiency in Swift, Kotlin, or React Native.Experience with mobile development frameworks (Flutter, Xamarin).Strong understanding of mobile UI/UX principles.Knowledge of app deployment processes.

ResponsibilitiesDesign, develop, and maintain software applications.Collaborate with cross-functional teams to define requirements and deliver scalable solutions.Participate in code reviews and improve software performance.Troubleshoot, debug, and upgrade existing systems.Job DescriptionDesign, develop, and maintain software applications while collaborating with cross-functional teams. The role involves writing clean code, performing debugging, and continuously improving software performance. QualificationsDesign, develop, and maintain software applications.Collaborate with cross-functional teams to define requirements and deliver scalable solutions.Participate in code reviews and improve software performance.Troubleshoot, debug, and upgrade existing systems.SkillsProficiency in programming languages such as Python, Java, or C++.Experience with software development methodologies (Agile/Scrum).Familiarity with version control tools like Git.Strong problem-solving and analytical skills.

ResponsibilitiesBuild and maintain both frontend and backend components of web applications.Collaborate with designers and other developers to deliver complete solutions.Write clean, scalable, and efficient code.Optimize applications for speed and scalability.Job DescriptionDesign and develop both frontend and backend components of web applications. The role focuses on delivering complete solutions and optimizing applications for performance. QualificationsBuild and maintain both frontend and backend components of web applications.Collaborate with designers and other developers to deliver complete solutions.Write clean, scalable, and efficient code.Optimize applications for speed and scalability.SkillsExpertise in frontend technologies (React.js, Angular).Proficiency in backend languages (Node.js, Java).Strong knowledge of databases (SQL, NoSQL).Familiarity with cloud services (AWS, GCP).

ResponsibilitiesBuild and maintain data pipelines and ETL processes.Design and optimize data architectures for analytics.Collaborate with data scientists and analysts.Implement data security and governance practices.Job DescriptionDesign and maintain data pipelines and ETL processes. The role involves building data architectures and collaborating with data scientists to deliver reliable and scalable data solutions. QualificationsBuild and maintain data pipelines and ETL processes.Design and optimize data architectures for analytics.Collaborate with data scientists and analysts.Implement data security and governance practices.SkillsProficiency in Python, SQL, and big data tools (Hadoop, Spark).Experience with cloud data platforms (AWS, GCP, Azure).Knowledge of data modeling and database design.Strong problem-solving and data management skills.

ResponsibilitiesDesign and implement cloud integration solutions.Develop and maintain APIs to support data integration between systems.Work with stakeholders to define integration requirements.Monitor and troubleshoot integration processes.Ensure data security and compliance with cloud integration best practices.QualificationsDesign and implement cloud integration solutions.Develop and maintain APIs to support data integration between systems.Work with stakeholders to define integration requirements.Monitor and troubleshoot integration processes.Ensure data security and compliance with cloud integration best practices.SkillsExpertise in cloud platforms like AWS, Azure, or Google Cloud.Strong knowledge of API development and management.Experience with integration tools (MuleSoft, Dell Boomi, etc.).Proficiency in scripting languages (Python, JavaScript).Understanding of cloud security protocols.

ResponsibilitiesAutomate and manage the deployment pipeline using CI/CD tools.Monitor and optimize cloud infrastructure.Collaborate with development and operations teams to ensure smooth software delivery.Implement security best practices in DevOps processes.Job DescriptionAutomate and manage deployment pipelines while optimizing cloud infrastructure. The role focuses on collaborating with development and operations teams for seamless software delivery. QualificationsAutomate and manage the deployment pipeline using CI/CD tools.Monitor and optimize cloud infrastructure.Collaborate with development and operations teams to ensure smooth software delivery.Implement security best practices in DevOps processes.SkillsExperience with CI/CD tools (Jenkins, GitLab).Proficiency in cloud platforms (AWS, Azure).Strong scripting skills (Python, Bash).Familiarity with containerization (Docker, Kubernetes).

ResponsibilitiesDesign and deploy secure network architectures.Monitor and respond to security incidents and threats.Implement firewalls, IDS/IPS systems, and VPNs.Perform regular security audits and vulnerability assessmenJob DescriptionDesign and implement network security solutions to protect organizational assets. The role focuses on securing network infrastructure, monitoring security threats, and ensuring compliance with security standards. QualificationsDesign and deploy secure network architectures.Monitor and respond to security incidents and threats.Implement firewalls, IDS/IPS systems, and VPNs.Perform regular security audits and vulnerability assessmenSkillsExpertise in network security tools and protocols.Experience with SIEM platforms like Splunk or ArcSight.Strong knowledge of network architecture and protocols (TCP/IP, DNS).Ability to perform penetration testing and threat analysis.

Oversee HR operations including recruitment, onboarding, employee engagement, and compliance.Develop and implement HR strategies aligned with business objectives.Manage performance appraisals and align them with company goals.Lead employee relations initiatives and foster a positive work culture.Handle disciplinary procedures and conflict resolution.Develop and maintain HR policies and procedures.Drive employee engagement, learning, and development programs.SkillsLeadership and people management skills.Excellent communication and interpersonal skills.Deep understanding of HR policies and procedures.Proficiency in HRMS and related software tools.Conflict resolution and problem-solving abilities.

ResponsibilitiesDesign and implement scalable cloud architectures.Collaborate with stakeholders to define cloud strategies and roadmaps.Optimize cloud infrastructure for performance and cost-efficiency.Ensure compliance with cloud security standards.Job DescriptionDesign and implement scalable cloud architectures for businesses. The role involves optimizing cloud infrastructure for performance, cost-efficiency, and security. QualificationsDesign and implement scalable cloud architectures.Collaborate with stakeholders to define cloud strategies and roadmaps.Optimize cloud infrastructure for performance and cost-efficiency.Ensure compliance with cloud security standards.SkillsExpertise in AWS, Azure, or Google Cloud.Strong understanding of cloud-native architecture.Experience with microservices, serverless computing, and containerization.Knowledge of cloud cost management tools.

ResponsibilitiesDevelop and deliver technical training programs for employees.Create training materials, guides, and resources.Conduct hands-on workshops and virtual training sessions.Assess employee progress and provide feedback.Stay updated on industry trends and update training programs accordingly.QualificationsDevelop and deliver technical training programs for employees.Create training materials, guides, and resources.Conduct hands-on workshops and virtual training sessions.Assess employee progress and provide feedback.Stay updated on industry trends and update training programs accordingly.SkillsStrong communication and presentation skills.Expertise in the relevant technology domain (e.g., programming, cloud, etc.).Experience in instructional design and e-learning platforms.Ability to simplify complex technical concepts.Excellent organizational and planning skills.

ResponsibilitiesFacilitate daily stand-ups, sprint planning, and retrospectives.Coach the team on Agile principles and practices.Remove blockers and ensure the team stays on track.Collaborate with Product Owners to manage the product backlog.Job DescriptionFacilitate Agile development processes as a Scrum Master. The role involves guiding development teams, removing impediments, and ensuring that Agile principles are followed. SkillsStrong understanding of Agile and Scrum methodologies.Excellent communication and leadership skills.Ability to manage multiple sprints and projects.Problem-solving and conflict resolution abilities.

ResponsibilitiesDevelop and execute digital marketing strategies across multiple channels (SEO, SEM, PPC, social media, etc.).Manage content marketing initiatives, including blogs, videos, and whitepapers.Analyze performance metrics and optimize campaigns for lead generation and brand visibility.Oversee marketing budgets and ensure effective use of resources.Lead a team of marketing professionals and coordinate cross-functional initiatives.Monitor trends in digital marketing and implement best practices.QualificationsDevelop and execute digital marketing strategies across multiple channels (SEO, SEM, PPC, social media, etc.).Manage content marketing initiatives, including blogs, videos, and whitepapers.Analyze performance metrics and optimize campaigns for lead generation and brand visibility.Oversee marketing budgets and ensure effective use of resources.Lead a team of marketing professionals and coordinate cross-functional initiatives.Monitor trends in digital marketing and implement best practices.SkillsExpertise in digital marketing tools (Google Analytics, SEMrush, HubSpot, etc.).Strong analytical skills and data-driven decision-making abilities.Excellent communication and leadership skills.Creative thinking and problem-solving mindset.Knowledge of the US staffing industry is a plus.

ResponsibilitiesIdentify and pursue new business opportunities through market research and networking.Develop and maintain relationships with clients and key stakeholders.Prepare and deliver compelling sales presentations and proposals.Collaborate with internal teams to align solutions with client needs.Achieve sales targets and contribute to revenue growth.Track and report on sales metrics and KPIs.SkillsStrong communication, negotiation, and presentation skills.Ability to build and maintain long-term client relationships.Proficiency in CRM software and sales analytics tools.Strategic thinking and business acumen.Experience in the IT or staffing industry is a plus.

ResponsibilitiesManage and process non-immigrant and immigrant visa petitions, including H-1B, L-1, TN, E-3, PERM, etc.Prepare and submit immigration documentation to USCIS, DOL, and other relevant agencies.Track visa status and ensure timely renewals and extensions.Provide guidance on immigration issues related to travel, status changes, and compliance.Act as a liaison between employees, legal counsel, and regulatory authorities.Maintain accurate records and ensure compliance with immigration laws and regulations.SkillsIn-depth knowledge of US immigration laws and processes.Strong organizational and time management skills.Excellent attention to detail and documentation abilities.Proficient in immigration management software and Microsoft Office Suite.Strong communication and interpersonal skills.

ResponsibilitiesDevelop and deploy machine learning models for various use cases.Optimize and fine-tune models for better performance.Integrate AI models into business applications.Monitor model performance and update algorithms as needed.Job DescriptionDesign and implement AI models and machine learning algorithms. The role involves collaborating with data scientists to build intelligent systems and deploying models in production. QualificationsDevelop and deploy machine learning models for various use cases.Optimize and fine-tune models for better performance.Integrate AI models into business applications.Monitor model performance and update algorithms as needed.SkillsProficiency in Python and machine learning libraries.Strong understanding of natural language processing (NLP).Experience with cloud-based AI services (AWS, Google AI).Strong problem-solving and analytical skills.

ResponsibilitiesDesign high-level architectural solutions.Collaborate with development teams to implement solutions.Ensure that systems meet scalability, security, and performance standards.Review and approve system designs and architecture.Job DescriptionDesign and oversee complex IT solutions that meet business needs. The role involves collaborating with stakeholders to align technical strategies with business goals and delivering scalable solutions.QualificationsDesign high-level architectural solutions.Collaborate with development teams to implement solutions.Ensure that systems meet scalability, security, and performance standards.Review and approve system designs and architecture.SkillsExpertise in cloud and software architecture.Strong knowledge of microservices and distributed systems.Excellent communication and technical leadership skills.Ability to translate business requirements into technical solutions.

ResponsibilitiesDevelop and implement security measures for networks and systems.Conduct regular security audits and risk assessments.Respond to security incidents and manage incident response plans.Provide training and guidance on cybersecurity best practices.Job DescriptionDevelop and manage security measures for networks, systems, and applications. The role includes conducting regular security audits and responding to security incidents. SkillsExpertise in network security, firewalls, and intrusion detection systems.Proficiency in SIEM tools like Splunk or QRadar.Strong knowledge of compliance standards (ISO, NIST).Experience with vulnerability assessment and penetration testing.

ResponsibilitiesProvide Level 1 and 2 support for IT issues.Install, configure, and maintain IT equipment and software.Troubleshoot network, hardware, and software issues.Document IT procedures and maintain knowledge bases.Job DescriptionProvide technical support to end-users and resolve IT issues. The role involves troubleshooting hardware, software, and network problems and ensuring smooth IT operations across the organization. QualificationsProvide Level 1 and 2 support for IT issues.Install, configure, and maintain IT equipment and software.Troubleshoot network, hardware, and software issues.Document IT procedures and maintain knowledge bases.SkillsStrong troubleshooting skills for hardware and software.Knowledge of Windows and Linux operating systems.Understanding of networking concepts and protocols.Excellent communication and customer service skills.

ResponsibilitiesDevelop and deploy machine learning models for various use cases.Collaborate with data scientists to refine models and optimize algorithms.Integrate ML models into production systems.Monitor model performance and retrain when necessary.Job DescriptionDevelop and deploy machine learning models for various use cases. The role involves working closely with data scientists and integrating models into production systems. QualificationsDevelop and deploy machine learning models for various use cases.Collaborate with data scientists to refine models and optimize algorithms.Integrate ML models into production systems.Monitor model performance and retrain when necessary.SkillsProficiency in Python and ML libraries (TensorFlow, PyTorch).Strong understanding of deep learning and NLP techniques.Experience with cloud-based ML platforms (SageMaker, GCP AI).Knowledge of data engineering and ETL processes.

ResponsibilitiesAnalyze business needs and configure ERP solutions accordingly.Manage ERP implementations and upgrades.Provide training and support to end-users.Collaborate with business stakeholders to optimize ERP functionalities.Job Descriptionmplement and manage enterprise resource planning (ERP) systems. The role involves configuring ERP solutions based on business requirements and providing ongoing support and optimization. QualificationsAnalyze business needs and configure ERP solutions accordingly.Manage ERP implementations and upgrades.Provide training and support to end-users.Collaborate with business stakeholders to optimize ERP functionalities.SkillsExpertise in ERP systems (SAP, Oracle, Microsoft Dynamics).Experience with data migration and integration.Strong analytical and problem-solving skills.Ability to manage multiple projects simultaneously.

ResponsibilitiesLead technical teams in the development, implementation, and support of IT solutions.Manage project timelines, resources, and deliverables.Collaborate with cross-functional teams to align technical efforts with business goals.Provide guidance on technical issues and resolve project roadblocks.Ensure adherence to coding standards, best practices, and quality assurance protocols.Oversee technical hiring, training, and performance management.QualificationsLead technical teams in the development, implementation, and support of IT solutions.Manage project timelines, resources, and deliverables.Collaborate with cross-functional teams to align technical efforts with business goals.Provide guidance on technical issues and resolve project roadblocks.Ensure adherence to coding standards, best practices, and quality assurance protocols.Oversee technical hiring, training, and performance management.SkillsStrong technical expertise in software development, systems engineering, or related domains.Proven leadership and team management skills.Excellent problem-solving and decision-making abilities.Proficiency in project management tools and methodologies.Strong communication and stakeholder management skills.