Systems Engineer in the Medical Device Sector

Position: Systems Engineer - Medical Device IndustryLocation: Newark, DEContract Duration: Long-Term Overview:We are on the lookout for highly proficient Systems Engineers to become integral members of our innovative team. The successful candidate will possess between 5-8 years of experience in the medical device field, with a keen emphasis on Design Controls, traceability, and design validation. This role is pivotal in ensuring that user needs are systematically linked to design inputs, verification, and validation throughout the entire product development lifecycle. Key Responsibilities:Design Controls: Spearhead the development and implementation of effective design control processes for both new and existing products, ensuring adherence to FDA regulations (21 CFR 820), ISO 13485, and pertinent industry standards.Traceability: Create and uphold traceability during the design and development stages, ensuring comprehensive documentation of user needs, design inputs, and verification requirements.User Needs to Design Validation: Collaborate across functions to connect user needs to design validation, confirming that the final product aligns with specified requirements and user expectations. This encompasses the formulation of detailed Design History Files (DHF) and validation records.Design Verification & Validation (V&V): Partner with various teams to guarantee that all products undergo meticulous design verification and design validation processes, demonstrating compliance with established specifications.Cross-Functional Collaboration: Engage closely with other engineering disciplines, including hardware, software, and quality assurance teams, to ensure cohesive integration of design controls and traceability throughout the product lifecycle.Documentation and Reporting: Develop and maintain comprehensive documentation for design control processes, ensuring that all outputs comply with both internal and regulatory standards. Provide regular updates to leadership and stakeholders regarding project status, risks, and timelines.Continuous Improvement: Identify opportunities for enhancing design control and traceability methodologies, implementing changes to improve the efficiency and effectiveness of product development. Required Qualifications:Experience: 5-8 years in systems engineering within a regulated environment, ideally focused on medical devices or similarly regulated sectors.

Position: Clinical Scientist – Medical DevicesLocation: Newark, DEContract Duration: Long TermRole Overview:The Clinical Scientist will play a pivotal role in the development of Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) to facilitate CE Mark regulatory submissions for innovative medical devices.Key Responsibilities:Expertly develop and author Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) essential for regulatory submissions.Perform comprehensive systematic literature reviews and analyze clinical data to verify device safety and performance.Collaborate effectively with Research & Development, Engineering, Regulatory Affairs, and Post-Market teams to enhance clinical strategy.Prepare essential clinical documentation including Investigator Brochures, Clinical Study Protocols, and Clinical Study Reports (CSR).Respond to inquiries from regulatory authorities regarding clinical evidence.Review risk documentation and product labeling based on clinical data insights.Manage timelines for clinical documentation and ensure adherence to EU MDR, GCP, and corporate SOPs.

ABOUT INSPIRE MEDICAL SYSTEMSInspire Medical Systems is pioneering a groundbreaking medical device aimed at transforming the lives of individuals suffering from Obstructive Sleep Apnea (OSA). Our FDA-approved technology is engineered to alleviate the severity of OSA in patients who have difficulties with CPAP devices. We are dedicated to improving patient outcomes through innovative sleep solutions and are guided by principles of integrity, respect, and positive persistence.WHY JOIN OUR DYNAMIC TEAMAt Inspire, we celebrate diversity and the unique experiences each individual brings. We foster a culture of inclusivity, offering numerous learning opportunities and a professional network that evolves into a supportive community. Our employee-centric approach includes competitive benefits, 401k matching, Employee Stock Purchase Plan (ESPP), flexible time off, and tuition reimbursement.If you are passionate about making a meaningful impact in people's lives and are eager to work with cutting-edge technology, we invite you to become part of our exceptional team!

Join our team as a Windows Systems Engineer, where you will play a key role in managing and optimizing our Windows server environments. Your expertise will contribute to ensuring high availability, performance, and security of our systems. You'll work closely with cross-functional teams to develop robust solutions and support our commitment to excellence in IT infrastructure.

Join our innovative team at Lucid Motors as a Staff Battery Systems Engineer. In this key role, you will be instrumental in developing cutting-edge battery systems that power our electric vehicles. You will collaborate with cross-functional teams to ensure our battery technology meets rigorous performance and safety standards.

We are looking for dedicated System Administrators and Networking Engineers to join our dynamic team. Ideal candidates should possess strong skills in UNIX and Linux systems, networking principles, and LAN/WAN configurations. You will be responsible for maintaining and optimizing our network infrastructure, ensuring high availability and performance.

Lucid Motors focuses on creating luxury electric vehicles that combine advanced design with a commitment to sustainability. The company aims to transform the driving experience by integrating performance, intelligence, and intuitive features into every vehicle. Design decisions at Lucid Motors balance individual needs with environmental impact. The team works to remove traditional barriers, giving customers new ways to experience mobility. Who thrives here People who value innovation and want to help shape the future of electric vehicles will find a strong sense of purpose. The company brings together individuals who care about design, technology, and making a positive difference. Community and culture Lucid Motors offers competitive salaries and a collaborative environment. Employees join a group of innovators dedicated to building a more sustainable future in the automotive industry.

Shaping the Future of Luxury Electric MobilityAt Lucid Motors, we strive to create breathtaking luxury electric vehicles that enhance the human experience and push the boundaries of space, performance, and intelligence. Our vehicles are designed to be intuitive, liberating, and forward-thinking, embodying the future of mobility. We aspire to lead in this new era of luxury electric vehicles by focusing on the core principles of exceptional design, ensuring that every decision we make serves both the individual and the environment. When freed from conventional constraints, we empower you to define your own journey. Join us and collaborate with some of the most talented professionals in the industry. We offer not only competitive salaries but also a community for innovators eager to make a meaningful impact. If you are passionate about contributing to a better, more sustainable future, this is the place for you.

Leading the Future of Luxury Electric MobilityAt Lucid, we strive to deliver the most captivating luxury electric vehicles that enhance the human experience while pushing the boundaries of space, performance, and intelligence. Our vehicles are designed to be intuitive, liberating, and forward-thinking, setting the stage for the future of mobility. We aim to excel in this new era of luxury electric vehicles by returning to the core principles of exceptional design—where every choice we make enriches the individual and our environment. When you break free from conventions, the possibilities for defining your experience are limitless. Join a team of highly accomplished professionals in the industry. We offer competitive salaries and foster a community of innovators eager to make a substantial impact. If you are passionate about creating a more sustainable future, this is the place for you.We are currently looking for a Senior System Engineer – ADAS/Autonomous Driving Safety to become a vital member of our ADAS/AD team.In this role, you will lead the functional safety (ISO 26262) and SOTIF foundation for our ADAS features, while also managing the safety case framework for our advanced automated driving functions. You will establish core safety processes, artifacts, and safety case architecture to support the scaling of our products as they evolve.This hands-on technical position will significantly influence our processes, tooling, and culture. You will serve as the internal reference for safety case methodologies and modern safety standards (ISO 26262, SOTIF, UL 4600, etc.).This role is based on-site at our Headquarters in Newark, CA.

Join us at the forefront of technology where we are revolutionizing the data storage industry. Here, you will be part of a team that thrives on innovation, personal growth, and collaboration with some of the brightest minds in the sector.If you are ready to embrace limitless opportunities and make a significant impact, we encourage you to be part of our journey!THE ROLE:Are you driven by a passion for innovation in the data storage sector? Do you excel at designing technical solutions that surpass client expectations? If so, Pure Storage has an exciting opportunity for you! We are looking for a skilled and enthusiastic Senior Pre-Sales Systems Engineer to join our vibrant team, focusing on the SLED market.In this role, you will be essential in understanding our clients' specific challenges and customizing Pure Storage solutions to address their individual needs. Working closely with the sales team, you will serve as a technical expert throughout the sales process, effectively communicating the value of our offerings.

Strive Health focuses on improving care for people living with chronic conditions. The team works to identify health risks early, coordinate care, and provide steady support throughout each stage of treatment. Every action centers on the needs of patients. Role overview As a Medical Assistant in Newark, NJ, the work helps reduce emergency room visits and supports better health outcomes for patients. The role involves direct interaction with individuals managing chronic conditions, aiming to help them lead healthier, more satisfying lives. Team members collaborate closely and share a strong commitment to making a positive impact each day. What you will do Support patients throughout their treatment journey Work alongside a team dedicated to patient-centered care Contribute to efforts that lower emergency room visits and improve daily outcomes What matters here Strive Health values teamwork, compassion, and a shared drive to enhance experiences for both patients and staff. The organization welcomes those who seek meaningful work and want their contributions to count.

Puro Storage seeks a Commercial Pre-Sales Systems Engineering Manager to lead its Northeast region team. This position is based in New York, NY or Newark, NJ, and centers on guiding a group of systems engineers who deliver storage solutions for commercial clients. Key Responsibilities Lead and support a team of pre-sales engineers working with clients throughout the sales process. Oversee technical pre-sales activities, ensuring proposed solutions align with customer requirements and expectations. Develop and maintain relationships with customers, serving as a trusted technical advisor. Work closely with the sales team to drive both customer satisfaction and revenue goals. Create and implement strategies that highlight the advantages of Pure Storage technologies. Location Details This role is based in either New York, NY or Newark, NJ, and covers clients and teams throughout the Northeast region.

Job Opportunity: Senior AIX System Administrator (Level 3)We are seeking a highly skilled AIX System Administrator with substantial expertise in managing and maintaining IBM AIX environments. The ideal candidate will demonstrate proficiency in the following areas:Installation, configuration, and maintenance of AIX Servers utilizing NIM.Strong knowledge of Power 7/Pseries configuration, including LPAR, DLPAR, and VIO concepts and their implementation.Configuration and administration of Logical Volume Manager (LVM).Tuning of kernel parameters for optimal performance.Patch management and package administration.Administration of printers and NIM servers.Expertise in troubleshooting mysysb backup failures.Proficiency in diagnosing hardware and operating system-related issues.Experience in configuring and administering HACMP clusters.Designing for system fault tolerance, business continuity, and disaster recovery planning.Certification in AIX 7 (IBM System Administration) is a must.

Join our team as a Medical Transport Specialist / Driver, where your role is crucial in ensuring safe and timely transportation of medical specimens. You will be part of a dedicated team committed to delivering high-quality medical services.

Join our dedicated team as a Medical Transport Specialist / Driver, where you will play a crucial role in ensuring the timely and safe transportation of medical specimens and patients. Your responsibilities will include adhering to safety protocols, maintaining vehicle cleanliness, and providing exceptional service to our clients. As a vital part of our operations, you will help improve patient outcomes through efficient logistics.

At WelbeHealth, we are dedicated to serving the most vulnerable seniors in our communities with compassion, innovation, and a commitment to meaningful care. Our core values guide our mission and inspire our team. As the Medical Director, you will play a pivotal role in leading and managing all medical care for WelbeHealth participants. This position is responsible for the design, implementation, and oversight of the WelbeHealth Quality Improvement (QI) program, along with all medical policies, procedures, standards, and protocols. You will also oversee our contracted specialty network of services and provide leadership and support among staff, colleagues, and community providers. Additionally, you may provide direct patient care as a PACE Physician when needed. Why this role is unique at WelbeHealth: You will be instrumental in launching WelbeHealth’s inaugural center in New Jersey. This position allows you to serve a smaller patient panel, enabling you to practice true value-based care and cultivate meaningful, long-lasting relationships in a mission-driven setting. We value our team members and offer a comprehensive benefits package, which includes: Medical insurance (including Dental and Vision) Work-life balance: Enjoy 17 days of personal time off (PTO), 12 recognized holidays annually, and 6 sick days. 401K savings plan with matching contributions. Competitive compensation package, including a base salary and performance bonuses. Additional benefits as outlined. Your day-to-day responsibilities will include: Formulating and upholding written objectives, policies, procedure manuals, and quality assurance programs for medical services, including annual reviews of all medical policies and procedures, and developing medical staff bylaws in collaboration with the medical staff. Engaging in the planning and budgeting processes for medical services. Coordinating and integrating medical services with other participant care initiatives to ensure a seamless continuum of care. Implementing medical staffing patterns effectively. Assisting in the creation and maintenance of job descriptions for medical personnel, reviewing credentials, delineating privileges, and assigning responsibilities based on relevant qualifications. Recruiting, training, and supervising PACE Physicians, Nurse Practitioners, community-based PACE Physicians, and other contracted medical staff, while actively participating in orientation and educational programs. Approving the continuity of care protocols and ensuring adherence to medical standards.

Join our dynamic team at HelloFresh as a Control Systems Technician, where you will collaborate closely with our maintenance team to ensure the optimal performance of our conveyance, automation, and facilities equipment. Your expertise will be pivotal in maintaining operational uptime and enhancing the reliability of our systems. In this role, you will be the go-to specialist in controls, PLCs, communication protocols, and automation technologies.Shift: Sunday to Wednesday - 9:00 PM to 7:30 AMYour Responsibilities:Ensure compliance with all safety, food safety, and security standards while conducting preventive maintenance and routine inspections on automation systems, robotics, and control panels.Diagnose and troubleshoot equipment issues, serving as an escalation point for junior technicians, and liaising with leadership and vendors for advanced troubleshooting as necessary.Maintain accurate documentation of all maintenance activities in the computerized maintenance management system (CMMS) and relevant ticketing systems.Mentor maintenance personnel to cultivate their skills and knowledge in automation, controls, and robotics.Lead root cause analysis for significant downtime incidents.Act as a resource for technical issues and facilitate network-wide root cause analysis.Enhance maintenance personnel's understanding of intermediate to advanced automation, controls, and robotics.Collaborate with engineering teams on the commissioning of new control systems.Evaluate vendor performance and provide feedback to leadership regarding quality of work and service level agreements (SLAs).Standardize and enhance preventive maintenance protocols across the network for increased efficiency and effectiveness.

We are seeking a skilled Business System Analyst to join our dynamic team. In this role, you will be responsible for analyzing business needs, identifying solutions, and ensuring that systems effectively support organizational objectives. You will collaborate with stakeholders to gather requirements, create documentation, and facilitate communication between technical teams and business units.

Join our dynamic team at Integrated Resources Inc. as a Guardium System Administrator or Analyst. In this role, you will be responsible for managing and analyzing Guardium systems, ensuring data security, and enhancing compliance measures. Your expertise will be crucial in implementing best practices and maintaining optimal performance of our data protection systems.

Join Our Dynamic Team!At DSI Systems, we bring over 40 years of expertise in sales enablement and tailored business solutions that create lasting value for our clients and partners. We are searching for enthusiastic individuals ready to leave their mark in sales and customer service. Our vibrant and fulfilling work atmosphere allows you to grow alongside us and make a meaningful impact.Position OverviewThe Retail Support Specialist (RSS) provides essential, on-the-ground support to AT&T customers in bustling national retail environments. In this role, you will directly interact with customers and retail partners to address account, billing, device, and service issues, often in fast-paced, high-volume situations. To excel in this position, you must possess excellent communication skills, emotional resilience, comfort with technology, and the ability to stay calm, precise, and professional in a lively retail setting. Key Responsibilities: Customer SupportDeliver professional, friendly, and solution-oriented support to AT&T customers in national retail locations.Resolve inquiries regarding billing, account updates, plan modifications, device assistance, and service issues.Troubleshoot wireless devices, network connectivity issues, and feature functionalities.Perform effectively in high-volume retail settings, maintaining focus, professionalism, and service quality even during peak traffic and escalated circumstances. Retail Partner SupportServe as the AT&T subject-matter expert for retail staff and third-party labor partners.Act as the primary AT&T representative for these partners, spearheading in-store support for retail escalations.Proactively collaborate with store leadership to resolve customer concerns, enhancing partnership alignment and ensuring a premier customer experience.Work Environment & Schedule ExpectationsThis position is conducted in a retail environment, requiring standing, walking, and engaging on the sales floor for up to 8 hours daily.Flexibility to work varied schedules, including evenings, weekends, and holidays, based on business needs.Comfort in busy, customer-facing environments characterized by frequent interactions and problem-solving demands.Operational ExcellenceEffectively navigate multiple systems while engaging with customers in real-time.Thoroughly document all interactions.Comply with company policies, compliance standards, and privacy regulations.Achieve or surpass performance metrics, including quality, efficiency, and customer satisfaction scores.Implement and uphold approved planograms for mobile devices and signage.