1307 Medical Devices Jobs - Page 22

Title - CAPA Engineer Location Pune experience 5+ Notice period - Immediate to 30 days QA CAPA. CAPA Quality Engineer,• Independently produces and completes CAPA records . • Responsible for performing timely, detailed CAPA engineering tasks like assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis, and quality problem-solving.,Additional support for CD related activity as approved by Dan Leonard for Priority 2 APEX Resource General - needed to support both ongoing CAPAs as well as CAPAs related to CD. Anticipated influx of 40-50 new CAPAs associated with CD audits. Reduces probability of us missing commitment dates for CAPs and in turn reduces financial penalties that the company has to pay.

We are looking for a skilled Technician to join our team at Vijaya Diagnostic Centre Limited, with 1-6 years of experience in the field. The ideal candidate will have a strong background in Biotechnology and be proficient in MRI technology. Roles and Responsibility Operate and maintain MRI machines for optimal performance. Prepare patients for procedures and ensure their safety during scans. Interpret images and provide preliminary reports to doctors. Collaborate with radiologists to diagnose medical conditions. Maintain accurate records of patient information and scan results. Stay updated with new technologies and techniques in MRI imaging. Job Requirements Proficient in MRI technology and its applications. Strong understanding of biotechnology principles and medical imaging concepts. Excellent communication skills for interacting with patients and healthcare professionals. Ability to work effectively in a fast-paced environment and prioritize tasks. Strong analytical skills for interpreting complex data. Familiarity with medical terminology and diagnostic procedures.

Responsibilities: * Design, develop & maintain medical equipment * Collaborate with healthcare teams on device implementation * Ensure compliance with regulatory standards * Conduct regular calibrations & quality control checks

Interested candidates may share their resume at "anurag.awasthi@medanta.org" Role & responsibilities Responsible for the installation of medical equipments. Rectify and reduce the breakdown time of medical equipments. Co-ordinate with vendors / company for the spare parts and preventive maintenance schedules. Inventory/ Assets management of medical equipment in the hospital. Leadership Skills Operational knowledge of the equipment present in the hospital Oversees the working of the biomedical engineers. Manages the staff present in the biomedical department and assists the engineers if required. Supervises the call management system at the Help Desk in the biomedical department. Develops and implements a plan for continuing professional growth Supervises and conducts the application training of the end users of all medical equipment. Supervises the creation of the Goods Receipt Note (GRN) and ensures that proper indent process is followed in transferring new medical equipment to the end user. Ensures that the complete procedure is followed in the procurement of new medical equipment and its handover to the end users Ensure that documents are maintained as per the accreditation norms Ensures that proper inventory records are being maintained of all the equipments in the hospital. Maintains all documents necessary for financial audits of the biomedical department and assists in the conduct of the same. Ensures the maintenance of all documents required for NABH, NABL and JCI requirements Maintains the quality standards of the hospital by ensuring that machines purchased are of correct technical specification Preferred candidate profile Strong knowledge of medical equipment standards and safety protocols. Familiarity with NABH/JCI compliance. Proficient in MS Office, CMMS (Computerized Maintenance Management System). Excellent communication, negotiation, and problem-solving skills.

Role & responsibilities : As a Regulatory Professional, the ideal candidate will be responsible to plan, prepare and submit high quality files to the authorities achieving fast approvals. The professional, act as an ambassador for assigned medical devices/device part of combination products. This role involves planning, coordinating and executing the regulatory tasks as required for existing device products in accordance with the Global Regulatory Device Strategy for the defined area of responsibility in collaboration with manager and colleagues. Preferred candidate profile

Bachelors degree in Science, Biomedical Engineering, Pharmacy, or a related field preferred. 1-3 years of experience in medical device sales or a related healthcare field. Excellent communication and interpersonal skills. Ability and willingness to travel frequently within the assigned region. Strong negotiation and presentation skills. Self-motivated, target-driven, and capable of working independently.

Promote products to healthcare professionals and establish strong relationships. Achieve sales targets and identify market opportunities. Salary : 4.5 LPA + Huge Incentives + Travel Allowance Call or WhatsApp to HR Suhaan@8882747284 Required Candidate profile Proven experience as a Medical Representative or similar role in the healthcare industry. Call or WhatsApp to HR Suhaan @ 8882747284 II HR Sana @ 7827482738 Perks and benefits Incentives + Travel Allowance + Bonus + Insurance

We are looking for a skilled Technician to join our team at Vijaya Diagnostic Centre in the healthcare industry. The ideal candidate will have 2-5 years of experience and be responsible for operating MRI machines, ensuring patient safety, and providing high-quality diagnostic services. Roles and Responsibility Operate and maintain MRI machines for optimal performance. Ensure patient safety during procedures and provide emotional support. Collaborate with radiologists to interpret images and make accurate diagnoses. Maintain accurate records of patient information and procedure details. Participate in quality control measures to improve patient care. Stay updated on new technologies and techniques in MRI imaging. Job Requirements Minimum 2 years of experience in an MRI setting or related field. Strong knowledge of medical imaging principles and practices. Ability to work effectively in a fast-paced environment. Excellent communication and interpersonal skills. Familiarity with hospital policies and procedures. Commitment to delivering high-quality patient care.

We are looking for a skilled Technician to join our team at Vijaya Diagnostic Centre, responsible for operating and maintaining MRI equipment. The ideal candidate will have experience in handling medical imaging technology. Roles and Responsibility Operate and maintain MRI machines for optimal performance. Prepare patients for procedures and ensure their safety during scans. Collaborate with radiologists to interpret images and provide accurate diagnoses. Maintain patient records and confidentiality. Stay updated on the latest advancements in MRI technology and techniques. Participate in quality control measures to improve patient care. Job Requirements Minimum 2 years of experience in an MRI setting. Strong knowledge of medical imaging principles and practices. Ability to work effectively in a fast-paced environment. Excellent communication skills for interacting with patients and staff. Familiarity with hospital protocols and procedures. Commitment to delivering high-quality patient care.

. Role & responsibilities Knowledge on Medical device regulations Good Communication skills Ability to read through the Medical Device Documents Ability to work on Microsoft tools (Excel, Word and PowerPoint) Experience on Medical Device UDI Data management will be an additional preference Preferred candidate profile Work location: Madurai Education: B.E Mechanical/Bio-Medical Experience: 6 months to 3 yrs Immediate joiners are only preferred. Interested candidates can share your resume to keeshouley.m@hcltech.com. Interview Mode - Scheduled Walkin (Need to report to Madurai premises for Face to Face Interview). Regards, Keeshouley M

We are looking for a highly motivated and experienced Sales Executive to join our team in the Pharma Medical industry. The ideal candidate will have 2-8 years of experience in sales, preferably in the recruitment or staffing sector. Roles and Responsibility Develop and execute sales strategies to achieve business objectives. Build and maintain strong relationships with clients and customers. Identify new business opportunities and expand existing customer relationships. Conduct market research and competitor analysis to stay ahead in the market. Collaborate with cross-functional teams to drive sales growth. Provide excellent customer service and support to ensure high levels of customer satisfaction. Job Requirements Proven track record of achieving sales targets and driving business growth. Strong knowledge of the Pharma Medical industry and its trends. Excellent communication, negotiation, and interpersonal skills. Ability to work independently and as part of a team. Strong analytical and problem-solving skills. Familiarity with CRM software and sales management tools.

Job Description Job Title: Risk Management SME Medical Devices Location: Pune Employment Type: Full-Time Experience: 10+ Years Industry: Medical Devices Job Summary: We are seeking a highly experienced Risk Management Subject Matter Expert (SME) with a strong background in medical device regulatory and quality systems. The ideal candidate will have 10+ years of experience working with cross-functional teams including RD, Regulatory Affairs, and Design Quality to ensure product compliance throughout the lifecycle. This role requires deep knowledge of risk management, global regulatory requirements (EU MDR, US FDA 510(k)), and relevant medical device standards. Key Responsibilities: Lead and execute risk management activities throughout the product lifecycle. Review and simplify Risk Management Files (RMF), Risk Mitigation Measures (RMM), BRDs, DHFs, traceability matrices, design requirements, and IFUs. Ensure compliance with global medical device regulations and standards (ISO 14971, ISO 13485, IEC 60601-1, IEC 62366-1, ISO 10993-1, MEDDEV 2.7/4). Collaborate with RD and Quality teams to validate design inputs (Usability, Safety, Reliability, etc.). Oversee and contribute to Verification Validation (VV) activities. Manage quality plans across all stages of the product lifecycle and ensure execution oversight. Conduct technical assessments and post-market analysis on product performance. Provide analytics and statistical reporting for post-market surveillance. Act as the primary quality representative in project teams ensuring design compliance at every milestone. Requirements: Degree in Mechanical/Electrical Engineering, Applied Sciences, or related field. 10+ years of experience in medical device industry focusing on risk management and regulatory compliance. Expertise in quality management systems (QMS) like ISO 13485, MDSAP, and EU MDR. Hands-on experience with quality and product development systems. Strong communication and cross-functional collaboration skills. Proven ability to drive quality excellence and compliance. Job Overview Posted date : 27 Jun 2025 Location : Any Location, India Experience : 10+ years

Description Position at Wind River [Senior] DevSecOps Engineer - Team ( IN ) - MTS Sr DevSecOps Engineer - Job Description Why Choose Wind River? In a world increasingly driven by software innovation, Wind River is pioneering the technologies to accelerate the digital transformation of our customers with a new generation of Mission Critical AI Systems in an AI-first world with the most exacting standards for safety, security, performance, and reliability. Success will be determined by our ability to innovate with velocity and sell at the solutions level. Wind River s impact spans critical infrastructure domains such as telecommunications, including 5G; industrial (automation, sustainable energy, robotics, mining), connected healthcare and medical devices, automotive (connected and self-driving vehicles), and aerospace & defense. We were recognized by VDC Research in July 2020 as #1 in Edge Compute OS Platforms, overtaking Microsoft as the overall commercial leader. Wind River regularly wins industry recognitions for excellence in IoT security, cloud and edge computing, as well as 8 consecutive years as a Top Work Place . If you re passionate about amplifying your impact on the world, in a caring, respectful culture with a growth mindset, come join us and help lead the way into the future of the intelligent edge! ABOUT THE OPPORTUNITY Wind River Systems is seeking an experienced high-performing DevSecOps software engineer for a position supporting a cloud-based application development team. The successful candidate will join a highly skilled development team delivering internal and external tools and technologies across a complete continuous testing platform providing support for test automation , pioneering many new industry leading capabilities. The successful candidate must have experience in cloud-native software development and be a highly adaptable team player who can quickly ramp up on new technologies and accomplish goals in a fast-paced agile environment. A combination of strong technical and communication skills is a must. ABOUT YOU Responsibilities: You will be responsible for managing, monitoring, and maintaining tools like GitLab, Jenkins and many more. Interact with Software Architects, Engineering Leads, and DevSecOps Engineers to follow company guidelines and best practices. Create and maintain effective and efficient CI and CD pipelines to deliver microservices images . Provide reporting from unit and automated test executions. Create and maintain Terraform Modules for each Kubernetes environment. Create and maintain Cloudify Blueprints. Work directly with a highly skilled development team to provide support for architectural design decisions. Work in a continuous integration - continuous delivery environment . Monitoring web application performance in a containerized environment. Helm charts design and maintenance Coach Junior Engineers to develop best practices in software development Requirements: Experience with Docker and Kubernetes Experience with cloud platforms such AWS , Google Cloud and Azure Experience in scripting language s like Bash , Python or Expect scripts (TCL) Experience in Continuous Testing Environments (unit tests, automated tests) Extensive experience working in software development Solid experience with NodeJS application development Experience working with Agile frameworks Experience collaborating effectively across remote teams and time zones, and collaborating with Senior Technical Leaders Experience with GIT, Jira, Gitlab and code review tools Excellent communication skills, both written and verbal. BSEE/BSCS or equivalent experience Nice to have: Experience with Terraform Modules is a plus Experience with Cloudify Blueprints is a plus Experience in Software development for critical devices. Experience in OS development

Principal Data Engineer full-time remote from anywhere in India #LI-Remote Description: The Principal will be responsible for supporting complex or leading singular projects related to data engineering requirements and initiatives across Research and Development. The Principal will support data projects from across the business including Clinical, Pre-Clinical, Non-Clinical, Chemistry, RWD and Omics. Essential Functions: Support the design, development and maintenance of data pipelines for processing Research and Development data from diverse sources (Clinical Trials, Medical Devices, Pre-Clinical, Omics, Real World Data) utilizing the AWS technology platform. Create and optimize ETL/ELT processes for structured and unstructured data using Python, R, SQL, AWS services and other tools. Build and maintain data repositories using AWS S3 and FSx technologies. Establish data warehousing solutions using Amazon Redshift. Build and maintain standard data models. Develop data quality frameworks, validation processes and KPIs to ensure accuracy and consistency of data pipelines. Implement data versioning and lineage tracking to support data traceability, regulatory compliance and audit requirements. Create and maintain documentation for data processes, architectures, and workflows. Implement modern software development best practices (e.g. Code Versioning, DevOps, CD/CI). Maintain compliance with data privacy regulations such as HIPAA, GDP May be required to develop, deliver or support data literacy training across R&D. Required Knowledge, Skills and Abilities: Strong knowledge of data engineering tools such as Python, R and SQL for data processing. Strong proficiency with AWS services particularly S3, Redshift, FSx, Glue, Lambda. Strong proficiency with relational databases. Strong background in data modeling and database design. Familiarity with unstructured database technologies (e.g. NoSQL) and other database types (e.g. Graph). Familiarity with Containerization such as Docker and EKS/Kubernetes. Familiarity with one or more RnD research process and associated regulatory requirements. Exposure to healthcare data standards (CDISC, HL7, FHIR, SNOMED CT, OMOP, DICOM). Exposure to big data technologies and handling. Knowledge of machine learning operations (MLOps) and model deployment. Strong problem-solving and analytical abilities. Excellent communication and collaboration skills. Experience working in an Agile development environment. Minimum Requirements: Bachelor s Degree in Computer Science, Statistics, Mathematics, Life Sciences, or other relevant scientific fields; Master s Degree preferred 3-5 years of experience in data engineering, with at least 1.5 years focusing on healthcare, research or clinical related data

QC Chemist Qualification - B.Sc Chemistry/B.Pharm with 2 years of previous experience in medical devices/pharma. Tasks : IPQC, RM/PM testing, Stability studies, BMR issuance & review, Monitoring of calibration of instruments & validation of equipments

QA Executive Qualification - B.Sc Chemistry/B.Pharm with 2 years of previous experience in medical devices/pharma. Tasks: Preparation, review & monitoring of Process Validation, machine validation, MOA, Specification, BMR, etc.Issuance, review & retention of all documents generated in organization

Medical Sales Representative - Gurgaon & Delhi/NCR (5 Days working) Job description Identify and pursue sales leads within the pharmaceutical sector, including healthcareproviders doctors, hospitals, clinics, and pharmacies.Develop and execute sales strategies to effectively convert leads into profitable business opportunities Network Building:- Market Analysis :-

Experienced in Medical Device industry with expertise in Embedded C/C++, RTOS, device drivers, and system design. Skilled in code analysis, testing, regulatory compliance (FDA Class I–III), and leading teams.

### Job Title: Development Engineer Plastic Injection Molding Medical Devices ### Company Overview: InnoIQ Engineering a Subsidiary of B&W Engineering und Datensysteme GmbH Germany is a leading company specializing in the research, design, and development of innovative medical devices. With a focus on precision, quality, and customer-centric solutions, we partner with global clients to bring advanced medical technologies to life. Our expertise extends from concept design and prototyping to production support, offering comprehensive engineering solutions for the medical device industry. For more details about our services and company profile, please visit www.innoiq.in Job Title: Development Engineer Medical Technology Plastic Injection Molding Location: Pune, Magarpatta Rd Department: Engineering / Product Development Employment Type: Full Time Reports To: Prashant Bobade About the Role: We are looking for a motivated and skilled Development Engineer to join our Medical Technology team, with a focus on plastic injection moulding . In this role, you will be responsible for designing and developing innovative products and components in a regulated environment, collaborating across disciplines and suppliers to bring high-quality medical products to market. Key Responsibilities: Develop new products and components in the field of medical technology Design, model, and dimension parts and assemblies using 3D CAD (preferably SolidWorks) Work collaboratively in interdisciplinary teams and with external suppliers/manufacturing partners Independently plan and conduct test series, including verification and validation activities Manage sampling processes for plastic components and prepare detailed assessments and evaluations Create and maintain manufacturing, testing, and development documentation in compliance with EN ISO 13485 standards Qualifications: Bachelor's or Masters degree in Mechanical Engineering , Medical Engineering , Plastics Engineering , or a related field Practical knowledge of plastic injection molding and plastics processing techniques Strong understanding of manufacturing processes and product development lifecycles Experience in 3D CAD design (SolidWorks preferred) Good communication skills and proficiency in English Ideally, initial experience in the medical technology industry What We Offer: A collaborative and innovation-driven work environment Opportunities for professional growth in the fast-evolving field of medical technology Involvement in meaningful projects that directly impact patient care and quality of life Flexible working hours / Hybrid work / International team / Training programs, etc A challenging role in a cutting-edge field with opportunities for professional growth. Competitive salary and performance-based incentives.

Evaluate complaints, maintain records, follow up for details, analyze trends, determine reportability, and document categories. Write investigation summaries. Proficient in MS Office, strong communication, multitasking, and proactive problem-solving.

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don t settle for the mediocre. Each of us is driven to help improve patients lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. Job Summary Job Title - Sr Manager - Materials Strategy Location - Whitefield, Bangalore Shift - General Job Responsibilities and Skills: Provide technical expertise for all the Materials related programs at a global front for both Sustaining and New product organization across Kidney Care Product Portfolio Subject matter expert for driving new materials selection for the container platforms across Drug Products organization Provide support for the trouble shooting and root cause analysis using statistical tools for any Polymer and Material related programs in alignment with the key internal stakeholders at a global front Proactively engage in the scoping, ideation, concept selection, and other key development decisions for all drug product, materials, and containers related projects. Drive alignment to the defined product portfolio vision and technology roadmaps through your active engagement. Developing Roadmaps for the future Kidney Care Solutions products. Provide technical expertise and lead technical program planning for any new container platform development and Formulations for drug products Design, lead and coordinate material testing with external and internal laboratories as the need arises Create design inputs and outputs/requirements documents for the new products as we'll as qualification strategy and plan. Identify and analyze design problems to achieve optimal solutions that satisfy cost and technical requirements using both internal and external technical resources. Formulate new, innovative approaches to solve technical problems on a consistent basis. Shape external collaborations with premier research institutes and contract research labs to explore new concepts in an efficient manner eg, novel materials, sustainability and best-in-class/new manufacturing processes. Communicate key information and recommendations to internal (purchasing, quality, marketing and production) and external partners to influence technical decisions and strategy. Develop global, business-strategy-aligned, materials and container technology roadmaps in support of the Kidney Care drug products portfolio Create and communicate project plans, tasks and deliverables and manage time to meet project deadlines. This includes reporting pertinent information at key milestones through clear, concise oral and written communications. Maintain an in-depth knowledge and understanding of GxP and regulations related to new product development. Demonstrate agile mindset in project executions - both in field issue resolutions and new product/material development. Demonstrated ability to innovate - through structured innovation process, leading and facilitating brainstorming sessions, coalescing diverging set of ideas into a solution that can be pursued and matured. Deep working knowledge about extrusion, injection molding and/or injection molding parts Understanding of mold flow studies and application of same towards solving technical problems Understand implications of a material change in a very broad perspective (product impact, process impact, regulatory implications, end user, sterilization etc) Demonstrated ability to design and execute and interpret results from material behavior, mechanical testing, and material characterization. Extensive experience in utilizing material characterization tools to solve problem oneself and coach/mentor a team of researchers. Proven ability to solve business problem at hand. Demonstrated ability to decompose complex problems into task lists and lead a team of senior scientists in ensuring on-time execution with attention to quality and first-time-right. Demonstrated ability to draw conclusions and make recommendations based on technical inputs from multiple and varied function (ie, manufacturing, quality, regulatory, etc) Proven communication skills and ability to perform in a cross-functional team environment Ability to drive change initiatives. Ability to work in a multi-cultural environment. Ability to coach and develop new team members. Good understanding of regulations applicable for drug and medical devices. Qualification: Holds a MSc or M. Tech with 15+ years or Ph.D. with 13+ years in one of the following disciplines - material science, polymer science, polymer engineering, or equivalent. Minimum of 12 to 15 years of diverse industrial experience in the given technical domains of interest. Reasonable Accommodation

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don t settle for the mediocre. Each of us is driven to help improve patients lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. Job Summary Job Title - Technical Leader - Drug Products and Sciences Location - Whitefield, Bangalore Shift - General Job Responsibilities and Skills: As Technical Leader, define, organize, plan and lead the projects that are technically complex and cross functional in nature at a global front Lead multi-functional project team for effective collaboration and deliverables Prior experience of managing diverse and cross functional teams at a global front Understanding of regulatory, process development, quality management systems, QbD tools, drug modelling and design of experiments in the field of drugs and medical devices Good knowledge of product development stages, Bio design process and life cycle management in the area of drugs and medical devices Prior experience with the new product and process development in the area of drugs, medical devices and combination drug/device systems Prior track record of translating new ideas to workable and commercially feasible products in the area of drugs and medical devices Being able to anticipate risks/challenges and willingness to deal with ambiguity Sound understanding of invention disclosures and patent filing processes Coordinate and ensure follow-up of technical activities in collaboration with key stakeholders, with respect of project commitment, quality procedures and business needs Propose options and develop action plans for problem-solving, product and process inventions and improvements Establish, maintain and update technical Design documentation according to Good Documentation Practices Fluent with Technical Writing, Documentation and reports generation Influential leadership and ability to flex as the role demands while interacting with internal and external stakeholders Out of the box and critical thinking ability Qualifications Ph.D/Masters in Pharmaceutics, Chemical Engineering, Biology, Biosciences and Biomedical engineering Minimum of 10 years of diverse industrial experience post Ph.D and about 15 years post Masters in the given technical domains of interest Desired if the incumbent had more than one jobs/roles and has interacted with many different global stakeholders in a given role Clear and effective communication (written, oral) and presentation skills. Good stakeholder management (local and global) A proven track record of effectiveness in a fast-paced environment. Proven ability to create results within budget, timeline, and product/project deliverables Skills Demonstrate strong project management and people leadership skills Ability to work independently Can effectively communicate with internal and external customers Demonstrates flexibility and the ability to shift gears between projects comfortably Fluency in English Good knowledge of Design Control documentation and medical writing Sound knowledge of international/regional/national regulations and standards for drugs and medical devices Acquire business acumen with time Experience with Statistics and Six Sigma tools Solid computer skills: email, documentation and collaboration tools: eg WebEx, Teams, Microsoft Office products, etc Reasonable Accommodation

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don t settle for the mediocre. Each of us is driven to help improve patients lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. Conduct testing and analyses of electromechanical medical devices through all stages of the development from prototype to design verification/validation stages. Execute and perform verification validation activities as per defined plan and protocol. Responsible for independently verifying and validating with minimal supervision. Develop and manage processes and tools required to support the verification and validation activities. Providing technical support as applicable. Clear understanding and proven experience on basic requirements of unit, integration and system level verification and validation requirements. Responsible for maintaining and upgrading the tools and methodologies used for the verification and validation activities. Ensures good documentation practices are followed in the VV process. Identify and report any quality or compliance issues during verification validation activities. Diagnose, isolate and investigate the problem reports, as applicable. Works with external test houses such as EMI, EMC tests for electrical boards and full device) to define the test scope, author the test plans, test procedures, execute consolidate the reports Participate in VV process continuous improvement and test automation activities. Adheres to Baxter Quality Management system. Bachelors / Masters Degree in Mechanical engineering, Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field. Reasonable Accommodation

The Regulatory Affairs (RA) Specialist is responsible for supporting the Regulatory Affairs department in global submissions, registrations, approvals, and audits; especially as it relates to footprints projects and sustaining activities. This is a great learning opportunity for someone interested in a Regulatory Affairs career in medical devices. Will train an enthusiastic, eager learner with a team attitude and passion for medical devices and helping patients thrive. PRIMARY DUTIES & RESPONSIBILITIES: Supports footprints projects with the ability to multi-task Assembles and submits documents for global registrations with direct oversight from the RA team Ensures all deadlines are met, paying particular attention to any government deadlines Collaborates with other departments to gather documentation needed for global submissions Responds effectively and timely to internal and external partners Tracks submissions and maintains applicable dashboards Prepares weekly reports on status of current items/issues to manager Organizes and maintains files, folders and databases to support the integrity of regulatory documentation Orders documents, subscriptions, articles, standards and other items; including Free Sale Certificates and Certificates to Foreign Government Coordinates audits as needed Coordinates notarization and authentication (legalization) of documents Coordinates shipment of documents (UPS, etc) and may also be responsible in coordinating samples Prepares data for audits, as needed Reviews publications to keep abreast of regulatory landscape for medical devices Performs special projects at the direction of the Regulatory Affairs Management May assist in the regulatory review of product claims and literature Job Requirements: REQUIREMENTS: bachelors degree in a related field plus 2 years of relevant work experience required, preferably in the Medical Device or Pharmaceutical industry or technical field.

Skills BSEE/BSCS or equivalent experience Strong knowledge of microservices architecture, design principles, and patterns. Solid experience in full stack development, including both frontend and backend technologies. Expertise in designing and developing RESTful APIs and integrating external services Proficiency in programming languages such as Python or Node.JS Strong experience with SQL, Database design, and DB migrations Strong experience with Git workflows Experience with frontend frameworks like Angular, Javascript and Typescript Strong Knowledge of CI/CD pipelines and related tools (eg, Jenkins, GitLab CI/CD). Experience with Docker and Kubernetes Experience with cloud platforms such AWS, Google Cloud and Azure BENEFITS Workplace Flexibility: Hybrid Work. Medical insurance: Group Medical Insurance coverage. Additional shared cost medical benefit in the form of reimbursements. Employee Assistance Program. Vacation and Time off: Employees are eligible for various types of paid time off. Additional Time off s - Birthday, Volunteer Time off, Wedding. we'llness Benefits through Unmind Carrot (Family -forming support)