95 Iso 13485 Jobs - Page 2

We are seeking a skilled Software Test Engineer with experience in the medical device industry to join our dynamic team. The candidate will collaborate closely with cross-functional teams, including clinical, product, software, firmware, and hardware teams, to ensure product quality and compliance with industry standards. This role involves defining test strategies, creating test plans, executing test cases, and implementing automation solutions. Requirements and Qualifications: Bachelor's degree in Computer Science or related field 4 years of hands-on experience in software testing 2 years of experience in the regulated medical device industry Hands-on experience with cloud-based SaaS applications Proficiency in developing API, Web, and Mobile (iOS and Android) test automation using tools like Cypress, API automation, Appium, TestNG, and Jenkins Familiarity with agile development methodologies and tools like JAMA, JIRA, and GIT Strong knowledge of HIPAA, ISO13485, and IEC62304 is highly desired Roles and Responsibilities: Collaborate with cross-functional teams to define use cases, write test plans, and execute test cases for medical devices Analyze product requirements and design appropriate test strategies and verification plans Ensure compliance with regulatory standards in coordination with the regulatory team Develop and implement automated test solutions to enhance product quality, robustness, compliance, and user satisfaction Identify, document, and track defects using issue tracking software (JIRA) Continuously improve testing processes and contribute to product lifecycle management

Role & responsibilities Job Summary : We are seeking an experienced and highly motivated IVDR Technical Manager to join our team. In this role, you will lead and facilitate necessary initiatives in order to ensure DNV complies with all regulatory and accreditation requirements relevant for in-vitro devices services and meet expectations on knowledge and competence from authorities, market units, customers and other partners. The ideal candidate will have a strong background in regulatory affairs, technical documentation, and quality management systems, with the ability to manage the technical aspects of IVDR compliance for a diverse portfolio of IVD products. Key Responsibilities : Competence Management Manage the competence process for all technical roles as per the accreditation and regulatory requirements in DNVs procedures. This includes the initial qualification as well as maintaining them. Cross-team Collaboration Work closely with the sales and planning functions, as well as other key internal stakeholders to enhance the operational cooperation and interaction within the IVDR services delivery and promote best practice sharing. Ensure to provide or address technical support when needed to the same functions. Proactively identify and recommend process improvements. Compliance and Regulatory Updates Work with cross-functional teams to ensure all stakeholders are informed of IVDR requirements and compliance statuses. Stay updated on changes in IVDR, EU regulatory requirements, and industry best practices. Provide training and support to internal teams regarding IVDR compliance and regulatory updates. Team Development and Training Ensure the team have all the knowledge needed to carry out work to a high level. When and where required, identify training and development to guarantee there is a culture of continuous performance, Take part and be responsible for the hiring of new staff. Recognizing where the gaps are and building a team that is motivated, talented and diversified. Design an on-boarding program for new staff that is varied, engaging and ensures they are set up for success, Business Development Drive and implement the sales and business development initiatives to promote Medical certification services, Interface with customers and follow up on leads and sales conversions Addressing technical queries with customers Preparation of effort estimations and commercial proposals Lead generations through public webinars/workshops, representation on relevant forums Customer Relationship Management Building trusted relationships with customers and internal stakeholders Communication with customers on the execution status of the certification activities. Preferred candidate profile Education : Bachelors or Master’s degree in Life Sciences, Engineering, Medical Technology, or a related field. Experience : At least 10+ years of experience in regulatory affairs, technical documentation, or quality management in the medical device or in vitro diagnostics industry. At least 4 years of direct experience with IVDR or its predecessor, IVDD (In Vitro Diagnostic Directive). Experience in preparing and submitting technical files, design dossiers, and risk management documentation for IVD products. Skills & Competencies : Strong understanding of the IVDR and EU regulatory requirements for IVD products. Excellent knowledge of technical documentation practices, including risk assessments, clinical evaluations, and performance studies. Knowledge of ISO 13485 and other relevant standards for medical devices/ invitro devices. Experience working with Notified Bodies and regulatory authorities. Exceptional problem-solving and analytical skills. Excellent organizational and time management abilities Strong communication and project management skills, with the ability to work collaboratively in cross-functional teams. Experience in auditing for IVDR compliance. Relevant exposure to commercial activities/business model.

We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team and play a key role in ensuring the regulatory compliance of our engineering services projects for leading global Healthcare/ MedTech clients. You will work closely with our engineering and quality teams, as well as clients regulatory team, to navigate the regulatory landscape and ensure a smooth and successful product launch. Roles & Responsibilities : Collaborate with clients regulatory team to understand their specific regulatory requirements and strategies for its MedTech products. Provide regulatory guidance and support to our engineering and testing teams, ensuring that the system design, development, and testing activities comply with relevant regulations and standards (IEC 62304, FDA guidelines, ISO 13485, etc. ). Assist in the preparation and submission of regulatory documentation, including 510(k) premarket notifications or PMA applications (as applicable), ensuring completeness, accuracy, and adherence to regulatory guidelines. Monitor and track regulatory changes and updates, keeping the team informed of any relevant developments and advising on necessary adjustments to the project plan or system design. Conduct regulatory research and analysis, providing insights and recommendations on regulatory strategies and compliance requirements. Maintain up-to-date knowledge of relevant regulations, standards, and guidance documents related to medical devices. Support internal audits and regulatory inspections, ensuring that all documentation and processes are compliant. Collaborate with cross-functional teams (engineering, quality, marketing) to ensure that regulatory requirements are considered throughout the product lifecycle.

Candidates experience with ISO 15378/GMP, ISO 13485, and IQ, OQ, and PQ, particularly in relation to the pharmaceutical industry. Position :- Quality Assurance- Engineer- No of positions:- 1 Location:- Isnapur- Hyderabad Preferred candidate profile

Executive (RA, QA) ( Level I/ II) Executive (RA, QA) ( Level I/ II) subrat kumar 2025-04-24T12:40:11+05:30 Executive (RA, QA) ( Level I/ II) JC OrthoHeal Private Limited is looking for Executive (RA, QA) ( Level I/ II) to grow our footprints. JOB ID: OHRA250401 Job family Regulatory Affairs Position Title E xecutive (RA, QA) ( Level I/ II) Job Type Full Time Manjuser, Vadodara Nature of Work On-site Company Name JC OrthoHeal Private Limited Updated on 24.04.2025 OrthoHeal is a leading Med-Tech company specializing in orthopedic medical devices. The company focuses on improving post-operative orthopedic recoveries and innovating technologies to enhance patient care. OrthoHeal s flagship product, FlexiOH , is a cutting-edge orthopedic immobilization technology designed for comfort and effectiveness. About the Role: Executive (RA, QA) ( Level I/ II) will work with the regulatory team and Formulate or implement regulatory affairs policies and procedures. Key Responsibilities: Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced. Develop or compile all the necessary documents required for the regulatory submissions. Maintain the device registration status and ensure timely re-registration. Assist in providing support to the local and international distributors to register devices when required. Collect and analyse data of Legal and Regulatory requirements including mandatory label marking requirements. Assist in training staff in regulatory policies or procedures. Participate in the development or implementation of clinical trial protocols. Supports post market surveillance and vigilance activity when it is required. Maintain and upkeep of all regulatory information, technical file, licenses, and certificates. Draft applicable QMS procedures and formats as per ISO 13485 in the organization. Manage change control activities. Ensure the effectiveness of the quality management system. Set and track quality assurance goals. Documentation and Record keeping. Qualifications: Education : Graduation/ Post Graduate in Science. Skills: Basic computer skills. Able to work in a strict timeline. Strong organizational and persuasive skills. Good verbal and communication skills

Role & responsibilities BE/BTech/ME/M-Tech in Electrical & Electronics Engineering, with 7 to 9 years of experience New Product Introduction (NPI) and Product Life Cycle Management Candidate having expertise in Electrical/Electronics HW Circuit Design and development Candidate having expertise in Altium or CADENCE or Mentor Graphics Product Obsolescence Management/Sustenance and Value Engineering Understanding & on the job application of standards like ISO 14971, ISO 13485, IEC 60601-1 Understanding & exposure to regulatory aspects pertaining to FDA, MDR, NMPA, TGA, HC, MHLW Understanding & Exposure to D/P-FMEA, Design for Usability, Design for Manufacturing/Assembly, Design for Reliability Hands-on experience with tools like Track Wise, Clear-quest, Windchill, DOORs or equivalent

Job Position: PMS Service Medical Devices Complaints Handling Job Description: To handle medical device customer allegations in complaints management system . Candidate with knowledge on Medical devices usage, Complaint Evaluation, Investigation, Medical devices reporting including post-market surveillance (PMS) and CAPA. Roles and Responsibilities: To work on Complaint handling Process Evaluation, Regulatory Assessment, Investigation Work with lead in completing daily assignation. Organize and manage daily work allocation Complaints remediation using work instruction, compliance to process To drive efficiency and compliance. Collaborate with of cross function team (CFT) such as Intake, MDR, Investigation to execute the project and initiative. Daily status to lead associate Skills: 2 to 4 years of experience in Medical devices complaints handling or any PMS activities Working knowledge of appropriate global medical device regulations, requirements, and standards such as: CFR Parts 803, 806 and 820, ISO 13485, ISO 14971, EU Medical Device Directives/Regulations including MEDDEV Guidelines For Complaint Investigation Mechanical problem analysis skill needed An excellent communicator, both written and verbal Adopt to cross cultural differences Ability to work in a timeline driven environment Proficiency using tools such as Trackwise, Sales force, Service Max Educational Qualification: B.E./B.Tech (Bio-Medical, Mechanical), B.Pharm, BSc Bio Science Total working experience (TEX): 2 to 4 years Relevant experience (REX): 2+ years Interested Candidates reply me to this email ID : nagamathini.r@hcltech.com , with the below details with your updated resume. Applicable only for Hyderabad location - Hybrid model/ Short Joiners preferred. Candidate Name: Email: Phone: Exp.: Rev. Exp.: CTC: Exp. CTC: Current company: Notice Period: Location: Preferred Location: LWD: DOJ: Any Offers in hand currently:

Develop, implement, and maintain the QMS in alignment with ISO 13485:2016 standards. Create, review, and update QMS documentation, including quality policies, procedures, and work instructions. Support during External (Notified Body for ISO 13485:2016) and Corporate Audits and Provide real-time support to the auditors by delivering requested documents, records, and evidence. Maintain and update the Document Control System (Windchill) for controlled documents, including SOPs, work instructions, forms, and records. Ensure document revisions, approvals, and distribution align with company policies and regulatory requirements (ISO 13485, FDA, EUMDR, etc.). Coordinate with cross-functional teams to review and approve documentation. Maintain the periodic review the documents. Maintain and update the Learning Management System (SLMS) with training records. Track training completion rates and generate reports for management and audit purposes. Communicate training requirements to employees and provide reminders for upcoming deadlines. Assist in evaluating training effectiveness through feedback collection and performance metrics. Support internal and external audits by providing training records and evidence of compliance. Qualifications & experience: Education and Experience: BSC Biotechnology, B-Pharm / M-Pharm or related field from premier institutes 2-3 years of experience in Medical Device domain At least 1+ years of experience in training and Document controller. Skills: Strong analytical and problem-solving skills. Excellent written and verbal communication skills. Proficiency in QMS software and tools. Nice to Have : ISO 13485:2016 certification Soft Skills Excellent communication & interpersonal skills. High analytical skills. Able to run communicate effectively with senior leadership. Excellent problem-solving skills. Proactive to support both internal and external customers. Travel Percentage: None

Medical Writer / Technical Content Writer - Internship This internship is ideal for someone passionate about simplifying complex medical or technical information into clear, structured documents and engaging content. Required Skills: Draft and organise documents such as user manuals, work instructions, clinical evaluations, and regulatory submissions. Format documents according to internal templates and regulatory guidelines (e.g., ISO 13485, MDR, FDA, IVDR). Research and write blogs, articles, white papers, and social media content focused on regulatory trends, product safety, and medtech innovation. Contribute to internal knowledge bases and client training materials. Work with subject matter experts from R&D, Quality Assurance, and Regulatory Affairs teams to gather information. Gain exposure to technical writing tools, documentation control systems, and compliance workflows. Eligibility & Skills: Background in Life Sciences, Pharmacy, Biomedical Engineering, Biotechnology, or English. Strong writing and grammar skills, with an ability to explain scientific/technical concepts in simple terms. Interest in regulatory documentation and medical devices is a must. Basic proficiency in MS Office (Word, Excel, PowerPoint) or Google Docs. Prior writing samples (academic or creative) are preferred.

Manage high impact, complex sustaining & transfer projects that enables Philips to reduce risk, improve profitability, align with Philips strategic supply base and optimize supply chain flexibility. The primary function within this role is to execute engineering activities through the course of fast-paced, high quality transfer and sustaining projects. You will be responsible for driving meaningful and innovative product development, generating ideas/concepts in feature development to improve quality and reduce cost, as well as performing the role of a technical lead in taking the product development through manufacturing release while transferring products between suppliers and manage sustaining of different devices by following PDLM-MLD process. Your responsibilities: Design and detail components and systems, including conducting predictive analysis and calculations. Select materials and processes appropriate for those designs Obtain parts and create prototypes. Write test protocols, conduct tests, analyze data, and report results. Successfully interact with associates in other departments, such as Manufacturing Operations, Procurement, and engineering staff, to achieve project and product objectives. Develop new test methods and tools as necessary. Specify, acquire, and maintain lab equipment. Operate lab instruments such as micrometer, tachometer, manometers, flow meters, tensile and compression testers, data acquisition systems, environmental chambers, and computer programs. Be a highly motivated, self-disciplined, open-minded individual possessing hands-on skills. Requirements detailing, design specification preparation, implementation, test, and integration of Unit per the higher-level Requirement and - Design specifications/architectures. Ensures the mutual consistency and efficient integration of the separate modules in modular, easy-to-maintain units that meet the product specification. Understands and communicates the consequences of their design on the architecture. Determines the Unit interfaces (HW/SW) in close consultation with relevant disciplines. Ensures that there is proper documentation for his/her design. Keeps abreast of technical developments in own field through study of the literature and technical contacts and propagates it. Defines, execute, and take the lead in concept and feasibility studies with a limited scope to investigate the usability of new technologies. Contributes to technology roadmaps and other strategic-related activities. Takes technological or process-related improvements initiatives within the scope of at least the mechanical development group. Contributes to the Work Breakdown Structure/ the planning process of his/her area. Draws up personal schedule and reports on progress. Inspires team members to get the job done. Performs work in line with the processes that have been agreed in the department. You are a part of A high-impact, global organization within Philips that works across all modalities - The Supplier Transfer Excellence Team (STET). STET has been established as an entrepreneurial organization that focuses on fast-paced, high-quality portfolio transfers within the Philips global supply base to mitigate risk & maximize profitability. To succeed in this role, you should be having M.Tech / B. E/ B.Tech in Mechanical/ Automobile/ Industrial or Equivalent Engineering 10+ years of relevant experience in design & development of electro-mechanical sub-systems & systems. Strong communication and collaborative abilities proactively seeks out expertise and advice and input from others in a collaborative team-environment. In-depth knowledge and 8+ years of experience in the development of mechanical design Experience in creating design concepts and mechanical designs of complex parts or assemblies. Strong knowledge and experience in CAD/CAE. such Creo Experience in metal or plastic crafts (drilling, milling, etc.) would be appreciated Experience in PDM/ PLM (Windchill, Teamcenter etc) Good knowledge and experience with gate staged development governance, ideally familiar with ISO 13485 or FDA-regulated development processes. knowledge of medical requirements and regulatory standards is beneficial (such as IEC 60601-1) Capability to interact in cross-functional teams

Purpose Statement: Provide Software Quality Assurance support, to corporate software policies and regulations, at the Penang site. Provides support on software validation requirements to project teams that are implementing software systems and provides an independent review to teams. Key Responsibilities: Develop an in-depth knowledge of BSC s policies and procedures, especially those that apply to BSCs software. Understand and be able to explain how these policies achieve compliance with appropriate regulations and standards. Be able to interpret policies and regulations in support of a wide variety of software such as Custom, Off-The-Shelf, as well as everything from equipment controllers to database-driven solutions. Apply these policies and procedures to the site s software systems and computer-driven equipment. Be able to explain software validation deliverables to business owners of the applications. Ability to perform risk analysis on multiple systems. Create validation documentation for a wide range of software applications including equipment software. Provide guidance and direction on the acceptability of Software Quality deliverables, based on requirements and templates given. Requirements: Bachelors (or higher) degree in engineering with preference Computer Science. 5-7+ years of experience in medical device R&D quality engineering, systems and / or quality engineering supporting R&D projects, design assurance and documentation. Professional training and certification in in Quality Management Systems including ISO 13485, Risk management ISO 14971, design assurance / control, verification and validation. Sound understanding of medical device regulatory requirements for Class II and III medical devices. Project planning - resourcing, timelines, quality and budgets. Skilled in implementing Quality tools like design of six sigma, risk management, FMEA, FTA (Fault Tree Analysis). Preference for candidates with CQE certification or similar training and experience Proficient in project management tools like MS project. Experience in ISO 62304

Responsible for providing mechanical engineering support in the maintenance of project DHF deliverables in Requirements Management (RM) tool for new and sustaining medical device products (invasive and non-invasive). Key Responsibilities: Read and interpret technical drawings, procedures, and protocols. Import and maintains the project documentation in online RM tool throughout all phases of NPD and Sustaining. Investigates and evaluates the compliance requirements driven from organization s QMS/Work Instructions and validate the same in templates developed in RM tool. Investigates and evaluates existing RM tools/technologies - JAMA, Polarion etc. Investigates compliance gaps in project documents and resolve them with project stake holders. Collaborate with cross-functional process, method, and teams to understand and implement solutions to resolve compliance gap issues in documents. Performs validation of patches and versions of RM tool as and when available. Support multiple projects across different time zones - Asia, Ireland, and North America Qualifications: Mechanical Engineering ( B.E./B.Tech) with 8-10 years of experience. Preferred experience in management of DHF documentation during full life cycle of medical device as per ISO 13485, and ISO 14971 Preferred experience in RM tools like JAMA, Polarion, DOORS, Cockpit. Knowledge of MS Office Tools - Word, Excel, PowerPoint. Strong attention to detail with good communication skills. Strong strategic / analytical thinking and problem-solving abilities, with a data-driven approach to decision-making. Ability to collaborate and work as a team player. Nice to have experience in product lifecycle management software and tools. Willingness to work in an agile environment.

1. Regulatory Knowledge: Understanding of EU MDR 2017/745: In-depth knowledge of the MDR and its application to medical devices and accessories, including Annexes and specific requirements related to accessories. Accessory Classification: Familiarity with how accessories are classified under the MDR (whether they are classified as a medical device or fall under other regulatory frameworks). Knowledge of Harmonized Standards: Knowledge of relevant European harmonized standards and guidelines that apply to medical devices and accessories (e.g., ISO 13485, ISO 14971). 2. Quality Management System (QMS) Expertise: ISO 13485 Compliance: Strong understanding of ISO 13485 requirements and its application to both medical devices and accessories, ensuring quality management systems are in place. Document Control & Change Management: Experience managing the documentation process, ensuring proper records, specifications, and design files for both the medical device and its accessories. Risk Management: Knowledge of ISO 14971 for risk management, specifically in the context of accessories and their role in the overall safety of the medical device. 3. Product Lifecycle Management: Design and Development: Ability to oversee the quality aspects of product design and development for accessories, ensuring compliance with regulatory requirements from concept to delivery. Post-Market Surveillance & Vigilance: Experience in setting up post-market surveillance systems for accessories, including reporting adverse events and ensuring continued compliance after the product is on the market. Clinical Evaluation: Understanding of clinical evaluation requirements for both medical devices and accessories, ensuring safety and performance criteria are met. 4. Supplier and Vendor Management: Supplier Qualification and Audits: Skills in qualifying suppliers for the accessories, ensuring they meet the necessary regulatory and quality standards. Supplier Quality Assurance: Managing quality expectations for external suppliers, especially if accessories are sourced from third-party vendors. 5. Cross-functional Collaboration: Collaboration with R&D and Design Teams: Ability to work closely with design and engineering teams to ensure quality is incorporated into the accessory's design from the start. Regulatory Affairs Coordination: Work with the regulatory affairs team to ensure accessories are compliant with applicable regulations before market release. Customer and Stakeholder Communication: Effective communication with internal stakeholders and customers about the accessorys quality and regulatory status. 6. Training and Leadership: Team Leadership and Training: Ability to lead and train teams on the quality standards required for accessories, promoting a culture of quality. Internal Audits and Compliance Checks: Expertise in conducting internal audits to assess compliance with MDR and ISO standards for accessories, identifying areas for improvement. 7. Problem-Solving and Continuous Improvement: Root Cause Analysis: Expertise in identifying and analyzing quality issues related to accessories, utilizing tools such as CAPA (Corrective and Preventive Actions) and root cause analysis. Continuous Improvement: Driving a culture of continuous improvement, including the application of Lean, Six Sigma, or similar methodologies to optimize processes related to accessories. 8. Knowledge of EU Market Authorization: CE Marking for Accessories: Familiarity with the requirements and process for obtaining CE marking for accessories, including the necessary technical documentation, risk assessment, and clinical evaluations. Conformity Assessment Procedures: Knowledge of the conformity assessment process under the MDR for both the medical device and its accessories, including involvement of Notified Bodies if applicable. bodies, especially for post-market surveillance, vigilance, and compliance audits. 9. Language and Communication Skills: Multilingual Communication: If dealing with international suppliers or regulatory bodies, proficiency in relevant languages (e.g., English, German) would be beneficial for effective communication and documentation. Technical Writing Skills: Ability to create clear and concise technical documentation, including quality plans, reports, and regulatory submissions for accessories. 11. Software and Tools: QMS Software: Proficiency in using quality management software systems to track documentation, CAPAs, audits, and regulatory compliance. Risk Management Tools: Familiarity with risk management software tools to assess, mitigate, and document risks associated with accessories.

Skills & Keywords: Regulatory Affairs | RA Compliance | Medical Devices | Pharma Regulatory | FDA | CE Marking | ISO 13485 | Clinical Research | Quality Assurance | Risk Management

Job Overview TE Connectivitys Quality and Reliability Engineering Teams analyze the ability of product and production systems to comply with customer and contractual requirements through established reliability factors. They design, recommend revisions and install quality control systems, develop and document analytical methods for establishing reliability of products and their components and conduct analysis on relative reliability with regards to cost, structure, weight, maintainability, facility of production, and availability of materials and equipment. Out teams develop, implement and monitor company environmental safety programs and policies to ensure compliance with federal, state, and local environmental, health and safety regulations and recommend corrective actions if necessary. They are responsible for policies and practices to comply with applicable government regulations and industry requirements related to product environmental compliance, the implementation and management of technical and testing standards and specifications, quality control and reliability programs governing materials, product and processes, resulting in the optimization of material and labor, as well as failure analysis, root cause, corrective action and customer communication. Roles & Responsibity: Works with cross-functional and cross-site teams to improve quality system procedures and practices. Implements changes globally to the QMS as driven by internal and external factors. Drives harmonization of QMS processes; works with sites to develop implementation plans, ensure site activities are completed as planned, monitor implementation and effectiveness. Participate in eQMS System integration and harmonization activities for new sites and businesses as acquired. Manages eQMS Technical Issues (trouble shooting) and escalation(s) within the SmartSolve TE Medical enterprise system. Manages TEIS Administrative tickets in line with business SLA timelines. Works with the Business Intelligence team to drive harmonisation in data collection and reporting Globally. Carry out training on harmonized processes as required. Applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving issues. Proactively liaises with Quality Systems leaders and local implementation project teams to ensure project milestones and project deliverable are achieved. Takes part in Global Compliance projects defined by the Global QS Compliance team. Reporting directly to the Global Quality Systems Manager. Minimal requirements: Bachelors Degree with a scientific or engineering emphasis. Minimum of 2 years related experience working at a progressively responsible level. Working knowledge of regional and international quality system requirements including 21CFR 820 and ISO 13485. Must have a good working knowledge of quality system requirements and how each quality system element connects. Well organized with a strong ability to prioritize tasks and work on own initiative through independent judgement. Good written and verbal communication skills. Fluent in English, Spanish is an advantage Creative and innovative thinking skills Competencies Values: Integrity, Accountability, Inclusion, Innovation, Teamwork

We are seeking a skilled Software Test Engineer with experience in the medical device industry to join our dynamic team. The candidate will collaborate closely with cross-functional teams, including clinical, product, software, firmware, and hardware teams, to ensure product quality and compliance with industry standards. This role involves defining test strategies, creating test plans, executing test cases, and implementing automation solutions. Requirements and Qualifications: Bachelor's degree in Computer Science or related field 4 years of hands-on experience in software testing 2 years of experience in the regulated medical device industry Hands-on experience with cloud-based SaaS applications Proficiency in developing API, Web, and Mobile (iOS and Android) test automation using tools like Cypress, API automation, Appium, TestNG, and Jenkins Familiarity with agile development methodologies and tools like JAMA, JIRA, and GIT Strong knowledge of HIPAA, ISO13485, and IEC62304 is highly desired Roles and Responsibilities: Collaborate with cross-functional teams to define use cases, write test plans, and execute test cases for medical devices Analyze product requirements and design appropriate test strategies and verification plans Ensure compliance with regulatory standards in coordination with the regulatory team Develop and implement automated test solutions to enhance product quality, robustness, compliance, and user satisfaction Identify, document, and track defects using issue tracking software (JIRA) Continuously improve testing processes and contribute to product lifecycle management

Location: Pune, India Work Mode: Hybrid Experience: 14-17 Years Role: Full-Time / Permanent About the Role: We are seeking a Senior Software Engineer (P5) to design, develop, and test software applications for medical software products . You will play a critical role in building innovative solutions for implantable medical device systems, ensuring compliance with regulatory standards while driving cutting-edge development. Key Responsibilities: Develop and test C#/.NET applications using WPF, UWP, SOA, and Entity Framework . Lead the end-to-end software development lifecycle , from requirements to deployment. Ensure compliance with medical device regulations (21 CFR Part 820, IEC 62304, ISO 13485). Implement best practices in software architecture, design, and code reviews . Utilize tools like Git (source control), Jira (issue tracking), Cockpit (requirements management), and Code Collaborator (code review) . Provide technical leadership and mentor a team of engineers. Collaborate cross-functionally with R&D, Quality, and Product teams to drive innovation. Required Skills & Experience: 14-17 years of experience in software development. Proficiency in C#/.NET, WPF, UWP, SOA, Entity Framework . Strong experience in Agile development and object-oriented design (OOD) . Knowledge of medical device software regulations (21 CFR Part 820, IEC 62304, ISO 13485). Hands-on experience with Git, Jira, Cockpit, and Code Collaborator . Strong communication, problem-solving, and leadership skills. Preferred Qualifications: Experience with Brainlab Surgical Planning Software . Familiarity with cloud technologies and microservices is a plus.

As a Senior Design Engineer specializing in wiring harnesses for medical equipment, you will play a critical role in the development of our innovative products. Your extensive experience in ISO 13485 Required Candidate profile Bachelor's degree in Electrical Engineering or a related field. 8-10 years of experience in wiring harness design for medical equipment, with a focus on ISO 13485 and UL compliance. Proficiency in CAD

Additional Locations: India-Haryana, Gurgaon Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we ll give you the opportunity to harness all that s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we ll help you in advancing your skills and career. Here, you ll be supported in progressing - whatever your ambitions. Purpose Statement: Provide Software Quality Assurance support, to corporate software policies and regulations, at the Penang site. Provides support on software validation requirements to project teams that are implementing software systems and provides an independent review to teams. Key Responsibilities: Develop an in-depth knowledge of BSC s policies and procedures, especially those that apply to BSC's software. Understand and be able to explain how these policies achieve compliance with appropriate regulations and standards. Be able to interpret policies and regulations in support of a wide variety of software such as Custom, Off-The-Shelf, as well as everything from equipment controllers to database-driven solutions. Apply these policies and procedures to the site s software systems and computer-driven equipment. Be able to explain software validation deliverables to business owners of the applications. Ability to perform risk analysis on multiple systems. Create validation documentation for a wide range of software applications including equipment software. Provide guidance and direction on the acceptability of Software Quality deliverables, based on requirements and templates given. Requirements: Bachelors (or higher) degree in engineering with preference Computer Science. 5-7+ years of experience in medical device R&D quality engineering, systems and / or quality engineering supporting R&D projects, design assurance and documentation. Professional training and certification in in Quality Management Systems including ISO 13485, Risk management ISO 14971, design assurance / control, verification and validation. Sound understanding of medical device regulatory requirements for Class II and III medical devices. Project planning - resourcing, timelines, quality and budgets. Skilled in implementing Quality tools like design of six sigma, risk management, FMEA, FTA (Fault Tree Analysis). Preference for candidates with CQE certification or similar training and experience Proficient in project management tools like MS project. Experience in ISO 62304 Requisition ID: 601996 As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn t just business, it s personal. And if you re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

Role & responsibilities 1. Product Registration & Certification - Support in preparing the documentation as applicable for the product registration and the certifications and submitting in a timely manner. - Update the documents, for response to queries and other requirements as required by respective regulatory authorities in a stipulated time frame. 2. Regulatory Audits -Internal and External Audit - Provide assistance in Internal & External audits. - Draft, Internal audit reports and coordinate with auditors for the closure of audits in a timely manner - Assist with follow-up audits, as required. - Follow-ups for the closure against identified NCs during audits. 3. QMS-Maintenance - Compile and maintain regulatory documentation databases as per ISO 13485:2016 and other applicable regulatory requirements of - Identify the related and required documents in line with processes ensuring quality standards. - On-time release, distribution & obsolete documents as per the company procedure. - Maintain the QMS documentation, records and file maintenance. - Coordination with other departments for maintaining the documents. - Timely preparation and submission of MIS report on a daily/weekly/monthly basis. Preferred candidate profile Looking for Regulatory affairs professional Experience into Regulations and maintaining the documentation as per the ISO13485, USFDA, MDSAP and other regulations. Overall documentation and guidance to the departments to maintain regulatory compliance.

Works with engineers to develop sampling, quality tools, and PFMEA. Leads PPAP, ensures supplier qualification via IQ, OQ, PQ. Manages supplier list compliance with strong Supplier Quality experience in medical devices.

Familiar with tools like JAMA, JIRA, DOORS, IBM SYNERGY, or PTC INTEGRITY. Knowledge of Quality Management, FDA guidelines, and defect tracking. Experience in regulated environments (ISO 13485, 21 CFR 820) is a plus

Bachelor’s degree in Engineering/Science and 8+ years in quality systems. Experience in Process Development, Validation, and MSA. Knowledge of FDA, ISO 13485, and Medical Device standards. quality tools skills.

We are seeking a skilled Software Test Engineer with experience in the medical device industry to join our dynamic team. The candidate will collaborate closely with cross-functional teams, including clinical, product, software, firmware, and hardware teams, to ensure product quality and compliance with industry standards. This role involves defining test strategies, creating test plans, executing test cases, and implementing automation solutions. Requirements and Qualifications: Bachelor's degree in Computer Science or related field 4 years of hands-on experience in software testing 2 years of experience in the regulated medical device industry Hands-on experience with cloud-based SaaS applications Proficiency in developing API, Web, and Mobile (iOS and Android) test automation using tools like Cypress, API automation, Appium, TestNG, and Jenkins Familiarity with agile development methodologies and tools like JAMA, JIRA, and GIT Strong knowledge of HIPAA, ISO13485, and IEC62304 is highly desired Roles and Responsibilities: Collaborate with cross-functional teams to define use cases, write test plans, and execute test cases for medical devices Analyze product requirements and design appropriate test strategies and verification plans Ensure compliance with regulatory standards in coordination with the regulatory team Develop and implement automated test solutions to enhance product quality, robustness, compliance, and user satisfaction Identify, document, and track defects using issue tracking software (JIRA) Continuously improve testing processes and contribute to product lifecycle management Skills : - Cypress, API automation, Appium, TestNG, Jenkins, JIRA, JAMA, GIT, SaaS applications, HIPAA, ISO 13485, IEC 62304, software testing, medical device testing, test automation, defect tracking, agile methodology

Role & responsibilities: • Be a part of core project team and support the quality engineering across the entire development cycle Lead product risk management, usability, reliability and design validation efforts for new product development and design change projects. Lead the development and implementation of design verification and validation plans with project design lead. Lead the development of Critical to Quality (CTQs), design input and output documents. Lead the fixture qualification and test method validation. Participate and implement tools like Design of Experiments (DOEs), FMEA sessions, Risk Management and ensure compliance to CTQs and safety requirements. Manage electronic document control and version control on all project related documents. Ensure adherence to the quality systems and design assurance SOPs and Boston Scientifics PLCP. Lead usability, reliability, testing, verification and validation testing internal and local vendors. Provide statistical testing and reliability plans. Provide quality and regulatory compliance guidance as needed to product development or design change project teams to assure country specific compliance to the laws and regulations of the targeted market for distribution. Ensure appropriate Project/Sustaining Quality Deliverables are created and properly executed (e.g. Project Design & Development Plan, Risk Management Plan, Hazard Analysis, Use and Design FMEA, Field Assessment Plan, and Software Validation Plan if applicable). Co-Lead CAPA efforts, and apply sound, systematic problem-solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues (e.g., 5 why’s analysis, Is-Is Not analysis, and Six Sigma problem solving methodologies). Devise and support the implementation of effective quality assurance, process controls, statistical analyses, and metrics that assure products meet or exceed quality. Skill Sets: Must have - Professional training and certification in in Quality Management Systems including ISO 13485, Risk management ISO 14971, design assurance / control, verification and validation. Sound understanding of medical device regulatory requirements for Class II and III medical devices. Project planning – resourcing, timelines, quality and budgets. Skilled in implementing Quality tools like design of six sigma, risk management, FMEA, FTA (Fault Tree Analysis). Preference for candidates with CQE certification or similar training and experience Proficient in project management tools like MS project. Experience in GD&T with statistical analytical techniques and s/w tools like Keywords & Tools: Quality Management Systems ISO 13485, Risk management ISO 14971, design assurance / control, verification and validation. Sound understanding of medical device regulatory requirements for Class II and III medical devices. development of Critical to Quality (CTQs) Quality tools like design of six sigma, risk management, FMEA, FTA (Fault Tree Analysis). Well versed MATLAB, MINITAB. GD&T CQE certification, CAPA