215 Iso 13485 Jobs

Key Deliverables : Plan and conduct audits in compliance with ISO 13485, EU MDR, and MDSAP standards. Review and evaluate technical files and documentation for medical devices. Collaborate with audit teams to ensure quality, compliance, and client satisfaction. Support certification decisions and regulatory reviews as per DNV and accreditation guidelines. Role Responsibilities : Execute audits independently and manage auditing teams when needed. Maintain audit documentation and timely delivery of reports. Ensure adherence to global regulatory and accreditation standards. Engage with clients and internal stakeholders to support quality assurance.

Job Description Summary Manages all Quality Assurance activities associated with the product development and product support processes in BD TCI. Ensures that all Design Control quality elements are established and documented to provide a safe and effective product that meets customer needs. Lead evolution and improvement of the product development process, policies and procedures which will enable design teams to respond rapidly to customer needs. Runs multiple projects directly while managing other quality engineering resources running separate projects. Provides leadership, quality oversight and direction, scheduling, decision-making, problem-solving and team-building capabilities. Maintains and expands QA/ QS and supervisory knowledge in areas applicable to Quality Engineering. Job Description Job Responsibilities Manages Quality Engineering staff and guides the Quality groups in BD TCI in support of product development. Leads development, sustenance, and continual improvement of quality systems in compliance with 21 CFR 820, EUMDR, and ISO 13485 quality systems with a specific focus on the design control requirements. Runs multiple projects directly while managing other quality engineering resources running separate projects. Ensures compliance with all local, state, federal regulations, and BD quality policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance principles. Leads design control compliance within the phase gate product development process as specified for the business. Lead evolution and improvement of the product development process. Leads or supports cross-functional planning, coordination, and reviews. Initiates and directs QA/ QS programs for effective introduction of new products and processes to fulfill the strategic plan. Leads Risk Management activities for products under design authority. Supports quality initiatives for Site issues. Work closely with Design Owner and Manufacturing sites globally to resolve customer complaint issues by identifying root causes and developing corrective actions. Act as a role model/Change ambassador to establish Inspire Quality initiatives through close collaboration with many partners to influence and lead the Quality strategy Analyze process and product non-conformances and implement comprehensive corrective and preventive action plans (CAPA) Knowledge and Skills Knowledge Bachelors degree in mechanical engineering or related discipline. Advanced knowledge of medical device regulations and practices (ISO 13485, 21 CFR 820, ISO 14971, EUMDR etc.), and quality assurance principles and concepts, total quality tools, continual improvement approaches, industry practices, and standards. Advanced understanding of design control, disciplined product development processes, regulatory, and quality requirements. Advanced leadership, motivational, and team building skills, with the ability to lead organizational change. Advanced interpersonal skills with the ability to manage, motivate, and influence both up and down the organization. Understanding of clinical setting and ability to understand customers quality and regulatory needs. Entrepreneurial drive and demonstrated ability to achieve stretch goals in an innovative and fast paced environment. Skills Minimum 5 years of experience in supervising technical/ quality professionals. Minimum 10 years relevant experience in design quality, quality record documentation, quality system requirements, GMP compliance, quality auditing, and CAPA systems, including or other applicable combination of education and experience. Required Skills Optional Skills Primary Work Location IND Bengaluru - Technology Campus Additional Locations Work Shift Show more Show less

Liaise with the reagent contract manufacturer and represent Beckman Coulter Quality in the interaction with the contract manufacturer and is responsible for the generation, analysis and reporting of quality metrics to relevant personnel and to ensure on-going improvement programs are put in place. Lead cross functional teams providing Quality guidance and guide in the determination of appropriate NC root cause analysis and implementation of effective corrective actions. Responsible for the Rework process, ensuring relevant documentation is prepared, reviewed and approved as per company procedures as well as completing Acceptable Quality Level (AQL) inspections prior to product disposition. Execute the Stop Ship process for finished product released to the market, in the Oracle system, ensuring process is compliant to relevant company procedures and perform CAPA (corrective and preventive action) activities and document in the CAPA system if required. Review & Approve document Change Controls (CCFs) and Equipment Change Controls (ECCs) ensuring Good Manufacturing Practices are maintained and comply with company procedures. Author relevant procedures, Review/Approve documentation (e.g. protocols, reports) ensuring compliance to applicable procedures and provide Quality expertise during the product life cycle. Review & Approve Certificate of Analysis(COA) for the finished goods.

Maintain and update QMS docs, lead audits, conduct QC checks, manage CAPA and supplier records, support training, ensure ISO 13485 compliance, and promote quality awareness. Diploma/Bachelor’s with 4–5 yrs in quality/manufacturing preferred.

Support production activities by maintaining and updating production records, performing in-process checks, ensuring compliance with ISO 13485, assisting in equipment and process validations, and supporting proper documentation and record retention.

Job Description Summary Manages all Quality Assurance activities associated with the product development and product support processes in BD TCI. Ensures that all Design Control quality elements are established and documented to provide a safe and effective product that meets customer needs. Lead evolution and improvement of the product development process, policies and procedures which will enable design teams to respond rapidly to customer needs. Runs multiple projects directly while managing other quality engineering resources running separate projects. Provides leadership, quality oversight and direction, scheduling, decision-making, problem-solving and team-building capabilities. Maintains and expands QA/ QS and supervisory knowledge in areas applicable to Quality Engineering. Job Description 6. Job Responsibilities . Manages Quality Engineering staff and guides the Quality groups in BD TCI in support of product development. . Leads development, sustenance, and continual improvement of quality systems in compliance with 21 CFR 820, EUMDR, and ISO 13485 quality systems with a specific focus on the design control requirements. . Runs multiple projects directly while managing other quality engineering resources running separate projects. . Ensures compliance with all local, state, federal regulations, and BD quality policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance principles. . Leads design control compliance within the phase gate product development process as specified for the business. Lead evolution and improvement of the product development process. . Leads or supports cross-functional planning, coordination, and reviews. Initiates and directs QA/ QS programs for effective introduction of new products and processes to fulfill the strategic plan. . Leads Risk Management activities for products under design authority. . Supports quality initiatives for Site issues. Work closely with Design Owner and Manufacturing sites globally to resolve customer complaint issues by identifying root causes and developing corrective actions. . Act as a role model/Change ambassador to establish Inspire Quality initiatives through close collaboration with many partners to influence and lead the Quality strategy . Analyze process and product non-conformances and implement comprehensive corrective and preventive action plans (CAPA) 7. Knowledge and Skills a. Knowledge . Bachelor's degree in mechanical engineering or related discipline. . Advanced knowledge of medical device regulations and practices (ISO 13485, 21 CFR 820, ISO 14971, EUMDR etc.), and quality assurance principles and concepts, total quality tools, continual improvement approaches, industry practices, and standards. . Advanced understanding of design control, disciplined product development processes, regulatory, and quality requirements. . Advanced leadership, motivational, and team building skills, with the ability to lead organizational change. . Advanced interpersonal skills with the ability to manage, motivate, and influence both up and down the organization. . Understanding of clinical setting and ability to understand customers quality and regulatory needs. . Entrepreneurial drive and demonstrated ability to achieve stretch goals in an innovative and fast paced environment. b. Skills . Minimum 5 years of experience in supervising technical/ quality professionals. . Minimum 10 years relevant experience in design quality, quality record documentation, quality system requirements, GMP compliance, quality auditing, and CAPA systems, including or other applicable combination of education and experience. Required Skills Optional Skills . Primary Work Location IND Bengaluru - Technology Campus Additional Locations Work Shift

Electronics Engineer Medical Device Product Development Location: Pune, Maharashtra, India Employment Type: Full-Time Experience Required: 57 years About InnoIQ Engineering InnoIQ Engineering, a subsidiary of B&W Engineering und Datensysteme GmbH (Germany), excels in research, design, and development of precision medical devices. From concept through regulatory compliance and production support, we deliver innovative, high-quality solutions for global clients in the medical device space. Role Overview As a key member of our team, youll lead electronics design for new medical devicesfrom schematic capture and PCB layout using Altium Designer , to component selection and prototype validation. Youll ensure full compliance with standards like IEC 60601, ISO 13485/14971, IEC 62366, and FDA 21 CFR 820. • Key Responsibilities End-to-End Electronics Design Drive schematic design and PCB layout from scratch using Altium Designer , including creation of symbols, footprints, library management, and templates. Perform detailed multi-layer board design with emphasis on signal integrity, EMI/EMC, thermal performance, DRC/ERC, and DFM/DFT. Components & Libraries Build and maintain Altium library assets (schematics, PCB footprints, 3D models), and manage lifecycle with traceability for compliance. Medical-Grade Standards & Design Control Design compliant with IEC 60601 (11 & 12), ISO 13485, ISO 14971, IEC 62366, and FDA 21 CFR 820 processes. Support DFMEA/risk management and maintain complete Design History File (DHF). Prototype & Test Develop and execute test setups for verification/validation, including electrical safety, EMC, and performance benchmarks. Debug via oscilloscopes, spectrum analyzers, and logic analyzers through first builds and pilot runs. Cross-Functional Collaboration Align with firmware, mechanical, QA, procurement, and manufacturing teams to ensure seamless integration and production readiness. Assist in NPI, including PCB prototype coordination, pilot transfers, and documentation handoff. Documentation & Leadership Prepare engineering documents: design specs, BOMs, assembly/test procedures, test plans, and validation reports. Lead schematic/PCB design reviews and mentor junior engineers. Required Skills & Experience Bachelors or Masters in Electronics/Electrical/Biomedical Engineering. 57 years in electronics design, ideally in medical-device or similarly regulated sectors. Proficiency in Altium Designer (schematic capture, multi-layer PCB layout, library and template creation). Solid knowledge of analog/digital circuit design, power distribution, sensor/MCU interfaces, high-speed considerations. Hands-on testing experience with oscilloscopes, logic analyzers, EMC analyzers. Understanding of medical standards: IEC 60601 series, ISO 13485/14971, IEC 62366, FDA 21 CFR 820. Excellent documentation skills, attention to detail, and teamwork orientation. Desired (Plus) Skills Experience in signal integrity, EMC/EMI mitigation, or high-speed board designs. Familiarity with embedded firmware collaboration or sensor-driven system design. DFMEA, obsolescence planning, and life-cycle management proficiency. Knowledge of RoHS, IPC standards, and medical usability engineering. Benefits Competitive compensation, performance bonuses Medical insurance and wellness initiatives Career growth, training, and certification support Collaborative global environment shaping medical-grade technology How to Apply Send your CV and cover letter detailing Altium-based schematic & PCB design experience in medical devices to career@innoiq.com with subject: Electronics Engineer Medical Device, Pune (Altium)

Job Title: Embedded Software Engineer Medical Device Technology Location: Pune Department: Engineering / Embedded Systems Employment Type: Full Time 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 strong focus on precision, quality, and customer-centric solutions , we collaborate with global clients to bring advanced medical technologies to life. From concept design and prototyping to production support , we offer comprehensive engineering solutions tailored for the medical device industry . Position Summary: We are seeking a passionate and detail-oriented Embedded Software Engineer to join our growing engineering team. You will play a critical role in the development of embedded software solutions for cutting-edge medical devices , ensuring compliance with regulatory standards and delivering high-quality products that positively impact patient care. Key Responsibilities: Design, develop, test, and maintain embedded software for medical devices Collaborate with cross-functional teams including electronics, mechanical, and system engineers Write efficient, reliable, and reusable code in C/C++ for embedded platforms Contribute to software architecture and system integration for real-time embedded systems Conduct software verification, validation, and unit testing in accordance with IEC 62304 Support design documentation and risk management activities per ISO 13485 and ISO 14971 Debug hardware/software integration issues using appropriate tools and methods Participate in design reviews, code reviews, and continuous improvement activities Required Qualifications: Bachelors or Masters degree in Electronics Engineering , Computer Engineering , Embedded Systems , or related field 2+ years of experience in embedded software development , preferably in the medical device domain Proficiency in C/C++ programming and real-time embedded systems Experience with microcontrollers , RTOS , and hardware-software interfacing Strong understanding of software development life cycle in regulated environments Knowledge of medical standards such as IEC 62304 , ISO 13485 , and ISO 14971 Good problem-solving skills and attention to detail Proficient in written and spoken English Preferred Qualifications: Experience with wireless communication protocols BLE, NFC Familiarity with version control systems Git and tools like Jira, Confluence Experience in developing software under Agile or V-model process Why Join Us? Be part of a global team developing life-enhancing medical technologies Work in a culture that values innovation , precision , and continuous learning Opportunities to grow in a fast-paced , quality-driven , and regulatory-compliant environment Exposure to international projects and collaboration with leading medical device companies

System Engineer /Sr. Systems Engineer Location: Pune, India Company: InnoIQ Engineering (Subsidiary of B&W Engineering und Datensysteme GmbH, Germany) Industry: Medical Devices / Engineering Services Employment Type: Full-time Role Summary: We are seeking a meticulous and detail-oriented System Engineer to join our growing team. In this role, you will be responsible for translating product needs into clear, structured, and testable requirements and specifications that guide engineering teams through the development of medical devices. You will act as a critical bridge between product management, design, and engineering teams, ensuring that all stakeholder needs are accurately captured and documented. About Us: At InnoIQ Engineering , a proud subsidiary of B&W Engineering und Datensysteme GmbH, Germany , we specialize in the research, design, and development of innovative medical devices . Guided by German engineering principles and a deep understanding of global healthcare needs, we deliver precision, quality, and customer-centric solutions . From early concept to production support, we serve as a strategic engineering partner to leading medical technology companies. TitleSystem Engineer /Sr. Systems EngineerQualification Bachelors or masters degree in Biomedical/ Electronics/Electronics & Telecommunication/Computer/Mechatronics Engineering Expected Experience 5-10 Years of Relevant Experience with minimum 3 years in medical device or other regulated industry Experience in New Product Development (NPD)/New product Introduction and Sustenance Engineering is a must Job Responsibilities Derives requirements from high -level requirements into product level requirements. Develop clear, concise, and testable specifications for hardware and software components of medical devices. Collaborates with multiple teams including client team, marketing/business development teams, technical teams, quality and regulatory teams to decompose needs statements into system product level requirements for medical devices and accessories Maintain traceability matrices and ensure alignment with verification and validation plans Participates in design reviews, including reviews of design inputs and outputs to ensure requirements are feasible and aligned with product goals. Keeps abreast of new developments in all relevant technological domains Envision, Desing, Build innovative solutions for customer Needs, Product & Services Ideation and conceptualization. POC development and prototyping Actively participates in design fraternity by sharing and learning best practices and gets involved in other organization initiatives Required Skills In-depth understanding of both hardware and software for integrated products Experience with tools such as DOORS, Jama, Polarion, or equivalent is a plus. Experience with embedded microprocessors and microcontrollers Experience with Product Design Hands on with ADC/DAC/Chemical Sensors Knowledge of IOT, Bluetooth, Wi-Fi, USB, File System for Embedded Platform Knowledge of global quality and regulatory environment for Medical devices including , FDA, EU MDR, MDD, IEC 60601-1-1(CE marking), ISO 13485, IEC 62304, ISO 14971 Strong understanding of Safety risk management, including FMEA, design mitigations, and risk management standards Strong Customer facing skills Effective verbal/written communication, documentation, presentation and interpersonal skills, as well as the ability to work both independently and as part of team Desirable Skills Firmware Experience with RTOS or Baremetal System level Circuit Modeling with EDA tools(or similar). SPICE Design of experiment (DOE) methodologies Design for excellence viz DFM, DFT, DFR Usability aspects of Medical devices according to HFE/HE75. IEC 62366, IEC 60601-1-6 etc What We Offer: Opportunity to work on cutting-edge medical technologies. Involvement in meaningful projects that directly impact patient care and quality of life A collaborative and innovation-driven work culture. Exposure to international projects and clients. Professional development and training programs. Flexible working hours / Hybrid work / International team / Training programs, etc Competitive compensation and benefits.

Job Description Summary Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area. Job Description Roles and Responsibilities GEHC ONLY Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms. Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy/strategy. A job at this level is likely to be an individual contributor, with proven interpersonal skills. Communication with direct colleagues and the business about design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward situations. Impacts projects, processes and procedures in own field. The role operates with some autonomy, but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment, but may require more senior levels of guidance. Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions. Possesses knowledge on QMS parameters with respect to ISO 13485 standards, including but not limited to, prior experience in handling Non-conformances, CAPA, Concessions and Deviations. In-depth and hands-on knowledge on process risk assessment and risk management with respect to ISO 14971 will be a key responsibility. Understands the process principles and drives the establishing, monitoring, and maintenance of all key performance indicators for product and process quality, with the support of cross functional teams for ongoing projects and new projects Demonstrate knowledge on Medical devices Refurbishment, Repairs and Harvesting. Required Qualifications For roles outside of the USA- This role requires advanced experience in the Quality Healthcare Quality. Knowledge level is comparable to a Bachelors degree from an accredited university or college ( or a high school diploma with relevant experience). For roles in USA - Bachelors degree from an accredited university or college (or a high school diploma / GED with at least 6 years of experience in Job Family Group(s)/Function(s)). Knowledge of standard and Regulations like ISO 13485, ISO 14971. Experienced with both Internal and External Audits in both Auditor and Auditee roles. Desired Characteristics Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills. Inclusion and Diversity GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you d expect from an organization with global strength and scale, and you ll be surrounded by career opportunities in a culture that fosters care, collaboration and support Relocation Assistance Provided: No

Job Description #EOS #PHILIN# Job title: Test & Verification Architect Your role: u00B7 u00A0u00A0u00A0u00A0u00A0 Ensuring right hardware verification strategy by delivering proper test coverage avoiding gap and overlap for release level requirements u00B7 u00A0u00A0u00A0u00A0u00A0 Leading verification work packages and assigning ownership within T&V team u00B7 u00A0u00A0u00A0u00A0u00A0 Ownership of planning, ensuring u00A0 timely execution u00B7 u00A0u00A0u00A0u00A0u00A0 Ensuring high quality of verification evidence ( including compliance with processes, regulations and standards) u00B7 u00A0u00A0u00A0u00A0u00A0 Boosting the effectiveness of the team by optimization of verification process u00B7 u00A0u00A0u00A0u00A0u00A0 Supporting/ leading problem solving activities in order to define root cause of the problem u00B7 u00A0u00A0u00A0u00A0u00A0 Mentoring and supporting team members within design verification process, development of tests methods and test equipment u00B7 u00A0u00A0u00A0u00A0u00A0 Managing stakeholders within and beyond own team, e.g. project managers, quality, development leads u00B7 u00A0u00A0u00A0u00A0u00A0 Effective collaboration and communication within cross- functional teams You will join the Test and Verification Team, a group within the Product Development Department of Grooming and Beauty Business Unit u2013 located in Drachten. The group consists of 30+ people, highly skilled, flexible, dynamic and multi-cultural. You will support verification of newly developed Philips products. You will work closely with Development Engineers, T&V and Quality. . You're the right fit if: To succeed in this role, you should have the following skills and experience u00B7 u00A0u00A0u00A0u00A0u00A0 Technical background, preferably electrical engineering, mechatronics, physics or comparable subject u00B7 u00A0u00A0u00A0u00A0u00A0 3+ years of experience in leading test and verification process u00B7 u00A0u00A0u00A0u00A0u00A0 5+ years of experience in R&D area or research laboratory u00B7 u00A0u00A0u00A0u00A0u00A0 Very good understanding of development process and testing (including medical devices (ISO 13485, 21CFR820)) u00B7 u00A0u00A0u00A0u00A0u00A0 Solid understanding of test method development, u00A0 MSA methodology/ test method validation, statistical techniques u00B7 u00A0u00A0u00A0u00A0u00A0 Strong leadership skills and project management skills u00B7 u00A0u00A0u00A0u00A0u00A0 Strong analytical skills (careful data analysis, effective research, creative thinking and efficient problem solving) u00B7 u00A0u00A0u00A0u00A0u00A0 Strong sense of ownership, passionate, fast learner u00B7 u00A0u00A0u00A0u00A0u00A0 Good practice of Windchill and Minitab is an advantage u00B7 u00A0u00A0u00A0u00A0u00A0 Very good communication skills (English) and social skills since you will be working with colleagues of many disciplines u00B7 u00A0u00A0u00A0u00A0u00A0 Ability to work in team u2013 flexibility in order to work with and provide support for number of people Minimum 2 years of experience with Bachelor's in areas such as Systems Engineering, Development Engineering, Supplier Quality Management, Manufacturing Engineering, Operations, Procurement or equivalent OR no prior experience required with Master's Degree. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the companyu2019s facilities. Field roles are most effectively done outside of the companyu2019s main facilities, generally at the customersu2019 or suppliersu2019 locations. Indicate if this role is an office/field/onsite role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. u2022 Learn more about . u2022 Discover . u2022 Learn more about . If youu2019re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care .

Are you a passionate product design ninja with 46 years of experience whos excited to work on meaningful tech that impacts lives Do you think, I dont want to just build pretty rendersI want to bring real medical products to life Someone who obsesses over both form and function and thrives in an agile, startup ecosystem. At Aindra, were building AI-powered medical devices for faster, accurate cancer diagnosticsand were looking for a Product Design Lead wholl shape the physical experience of our flagship products. We want you if you are: A passionate designer-engineer hybrid who dreams of building elegant and functional medical products Someone who takes ownership of the entire design lifecyclefrom concept to manufacture A 3D CAD expert (preferably Fusion 360) who can visualize, simulate, and build multi-module assemblies Familiar with electro-mechanical systems, optical components, and embedded electronics Adept at converting design concepts into GD&T-rich engineering drawings Comfortable working with suppliers and manufacturers to ensure real-world feasibility and quality A champion of simplicity, with a deep belief in design that empowers usability Able to collaborate across optics, electronics, and software teams with humility and clarity A problem solver who uses both creativity and engineering rigor Energized by speed, constraints, and the startup chaosand can still deliver excellence Curious about design for manufacturability, medical-grade materials, and ISO 13485 QMS requirements Required Technical and Professional Expertise: Degree in Mechanical Engineering 46 years of experience in full-cycle product design (preferably in MedTech or high-precision devices) Proficiency in 3D CAD tools like Fusion 360, including assemblies, exploded views, motion studies Expertise in GD&T, engineering documentation, and tolerance analysis Familiarity with manufacturing processes: Injection moulding, vacuum casting, silicone moulding, CNC, Milling, Turning, Thermo-forming, 3D Printing, sheet metal bending and cutting, etc.. Hands-on experience in prototyping (3D printing, mock-ups, early engineering models) Understanding of ISO 13485:2016 or similar regulated product development processes Experience working with interdisciplinary teams (hardware, optics, embedded, software) Experience in DFM (Design for Manufacturing), DFA (Design for Assembly) & DFS (Design for Serviceability) Exposure to design validation, FMEA, and field feedback loops Bonus: Experience in designing enclosures for medical imaging, diagnostic devices, or lab equipment Show more Show less

EY is hiring for Medical Device Assessor/Auditor for one of its clients. Location: Any metropolitan cities Work Mode Work from Home ( need to be flexible with hybrid) General Shift Travel – 100 % (75% Domestic) Notice – Immediate to 60 days Mandatory Skill set: Auditor, Assessor, MDR Assessor certification body in medical devices, regulatory approvals for medical devices. Job Description We have a opportunity for a Medical Device Assessor/ Auditor to join our India Team. The successful candidate will be responsible for, planning and conducting audits/ assessments, in accordance with ISO 13485, EU MDR, and MDSAP standards and related (eg IMDR). Key Accountabilities: Technical Compliances, Accreditation Requirements and collaborating with a Team of Auditors/ Assessors. Conduct audits (either desk-based or on clients sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships. Conduct Technical File reviews specific for products being authorized. Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business. Complete specific projects in relation to medical device procedures, processes, systems and documentation. If required, undertake reviews of packs and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements. Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards. To be considered for this role, youll require about 10 years of professional experience in relevant field of healthcare products or related activities e.g.: work in medical devices industry such as research and development, manufacturing, quality management, regulatory affairs: work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies. work in the application of device technology and its use in health care services and with patients. testing devices for compliance with the relevant national or international standards. conducting performance testing, evaluation studies or clinical trials of devices. 5 + years relevant professional experience in quality management is essential. In addition to the above youll also need to demonstrate the following. An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques Good knowledge of ISO 13485, MDD 93/42/EEC/ Indian Medical Device Regulations and their application Knowledge of MDR 2017/745, MDSAP, IMDR Work experience in positions with significant QA, Regulatory or management systems responsibility Experience with Harmonized medical device standards and for active & non active devices. Experience with Risk Management EN ISO 14971 Experience auditing against recognized standards Experience of working under own initiative and in planning and prioritizing workloads Solid knowledge of non-active devices Solid knowledge of sterilization processes The following attributes are essential: Work actively with a Team of Assessors/ Auditors. Experience of reviewing audit packs Review of technical documentation Registered IRCA lead auditor, or equivalent registration under other recognized body Interested candidates are requested to share their updated resume to mahesh.a2@in.ey.com

Quality Manager for Wiring Harness & Cable Assembl QMS Work with the Cross functional team to put together a Quality Management System encompassing the lifecycle of NPD projects comprising of initiation, planning, execution, control and close-out. Required Candidate profile 14+ years of experience in implementing ISO 9001,14001,IATF ISO 13485 in Manufacturing sector implementing Quality tools like Process capability MSA SPC FMEA PPAP APQP review quality performance KPIs

Job Title: Senior Supplier Quality Location: Bengaluru, Karnataka, India Employment type: Part-time Job Summary: We are seeking an experienced Supplier Quality Professional Trainer with 10+ years of expertise in managing supplier quality assurance , supplier development, and compliance in regulated industries (pharmaceutical, biotech, or medical devices). The role involves ensuring suppliers meet company , industry, and regulatory standards by leading audits, driving quality improvement initiatives , and building strong supplier partnerships. Job Responsibilities: Develop and manage supplier quality strategies, policies, and risk management processes. Lead supplier qualification, selection, and approval in alignment with regulatory standards (FDA, EMA, ISO 13485, ICH Q10, GMP). Conduct supplier audits, assessments, and performance reviews to ensure compliance with quality and regulatory requirements. Oversee supplier corrective and preventive actions (CAPA) , root cause analysis, and continuous improvement programs. Collaborate with cross-functional teams (procurement, R&D, operations, quality) to resolve supplier-related issues. Monitor supplier KPIs (on-time delivery, defect rates, deviations, complaints) and drive improvement initiatives. Support new product development (NPD) by ensuring supplier capability for components, raw materials, and services. Manage supplier change control processes and evaluate the impact on product quality and regulatory compliance. Train, mentor, and guide internal teams and suppliers on quality systems and compliance expectations. Ensure alignment with global regulatory requirements (FDA 21 CFR Part 11/210/211, ISO standards, EU MDR, ICH guidelines). Core Competencies & Skills Strong expertise in supplier quality management, auditing, and regulatory compliance . In-depth knowledge of GMP, GDP, ISO 9001, ISO 13485, IATF 16949 (if automotive/industrial) . Proficiency in risk management, root cause analysis, CAPA, Six Sigma, and Lean methodologies . Excellent communication, negotiation, and stakeholder management skills. Ability to lead supplier development programs and strategic quality initiatives. Experience in global supplier management and multicultural environments. Qualifications: Bachelors/Masters degree in Engineering, Life Sciences, or related field. 10+ years of experience in supplier quality assurance, preferably in pharma/medical devices/regulated manufacturing industries. Certified Lead Auditor (ISO 9001/13485, GMP, or equivalent) preferred. Six Sigma Green/Black Belt certification is a plus. Proven track record in managing global suppliers and delivering measurable quality improvements. Show more Show less

Role & responsibilities The Regulatory Affairs (RA) & Global Registration Executive/Manager will be responsible for managing end-to-end global regulatory submissions, maintaining compliance with regional and international regulatory requirements, and facilitating timely registration and market access for medical devices across multiple geographies. Prepare and submit dossiers (510k, CE, CDSCO, etc.) as per country-specific regulations. - Maintain registration records and handle renewal processes. Monitor global regulatory updates and assess product impact. - Coordinate with QA, R&D, and marketing for data collection and documentation. - Respond to regulatory queries and deficiency letters. Support audits and inspections by regulatory bodies. Preferred candidate profile Knowledge of global regulations: USFDA, MDR, CDSCO, TGA, SFDA, etc. Hands-on with portals: eSTAR, SUGAM, EUDAMED. Experience in technical file creation, labeling, UDI, and ISO 14971 risk documentation Strong communication and documentation skills - Attention to detail and time management Proficient in MS Office - Problem-solving and multi-tasking abilities

Job Title: Regulatory Affairs Specialist Med/Pharma (Female) Location: Remote Position Overview: We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines). The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization. Key Responsibilities: Prepared, reviewed, and submitted regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications. Ensured compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices. Interacted with regulatory authorities (FDA, EMA, CDSCO, MHRA, Notified Bodies) during product submissions, inspections, and audits. Developed and maintained regulatory strategies to support new product development and lifecycle management. Reviewed labeling, promotional materials, and product packaging for compliance with applicable regulations. Maintained up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance. Supported quality systems in alignment with ISO 13485, ICH, and FDA QSR standards. Collaborated with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development. Assisted in responding to regulatory queries, deficiency letters, and inspection findings. Managed regulatory documentation archives and maintained compliance records for audits and inspections. Show more Show less

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position Job Description We are looking for a skilled & driven Product Owner with a strong technical background and experience in the healthcare domain. The ideal candidate will lead the product /platform development efforts, ensuring seamless integration with LIS, EMR, and EHR systems, and compliance with healthcare regulations like HIPAA and GDPR. This role requires expertise in agile product management, backlog prioritization, and healthcare interoperability standards such as HL7, FHIR, and DICOM. The Product Owner will serve as the bridge between technical teams, stakeholders, and end users to deliver impactful, innovative, and compliant healthcare solutions. Roles & Responsibilities Collaborate with stakeholders & technical product managers to define and execute the product vision, strategy, and roadmap. Define and prioritize the product backlog, ensuring alignment with business objectives and customer needs. Write clear, detailed user stories and define acceptance criteria for successful implementation. Work closely with cross functional stakeholders including regulatory & engineering teams - Development, QAs & DevOps to ensure technical feasibility and timely delivery of features. Ensure compliance with healthcare standards and regulations, including HIPAA and GDPR. Drive end-to-end integration with LIS, EMR, and EHR systems, ensuring interoperability through standards like HL7, FHIR, and DICOM. Leverage domain knowledge to address challenges in healthcare workflow automation, data sharing, and interoperability. Facilitate agile ceremonies, including sprint planning, daily stand-ups, retrospectives, and PI planning. Act as the technical and functional subject matter expert for healthcare-related integration requirements. Lead SaMD-specific documentation: product requirements, risk assessments, validation records, user manuals, and regulatory submissions. Define and own the SaMD product roadmap, aligning with business goals, regulatory standards (e.g., ISO 13485, IEC 62304), and user needs. Ensure risk management and compliance through standards-based hazard analysis, cybersecurity evaluation, and regulatory alignment (e.g., FDA/EU MDR or GxP) Engage external vendors or legal manufacturers, aligning deliverables with internal standards and regulatory expectations. Qualifications: Bachelor's/Master's degree in Engineering (Computer Science/IT) with 8+ years of experience in building healthcare related software products. Proven experience as a Product Owner in the healthcare domain - especially around SaMD - Software as-a Medical Device, & with LIS, EMR, and EHR integrations. Good technical expertise, with familiarity in APIs, data security, and interoperability standards (HL7, FHIR, DICOM). SAFe Product Owners/Product Manager Certification, Certified Scrum Product Owner (CSPO) or similar agile certification. Hands-on experience in working with teams using SAFe. Excellent skills in writing user stories, defining acceptance criteria, and managing product backlogs. Ability to work effectively with cross-functional teams in an agile environment. (Business, Architects, POs, Devs, QAs and Executive leaderships) Strong problem-solving abilities and attention to detail in a fast-paced development lifecycle. Exceptional interpersonal and communication skills, with the ability to bridge gaps between technical and non-technical stakeholders. Good understanding of healthcare compliance and data privacy regulations (e.g., HIPAA, GDPR). Why Join the AlgoSuite team at Roche Our team is building the next generation platform called navify AlgoSuite , which makes the high medical value algorithms accessible to the hospitals, labs and healthcare professionals and in-turn helping large numbers of patients across the world. That is why we come to work every single day and commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. Who we are A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let's build a healthier future, together. Roche is an Equal Opportunity Employer.

Qualification: B.E/MCA degree (CSE/ISE/Electronics) Experience: 4 8 years of Hands-on experience with Application Lifecycle Management (ALM) tools, model-based systems engineering (MBSE), and a strong understanding of compliance, quality management, and IT service processes. Relevant certifications in ALM tools, ITIL, or quality management systems will add value. Responsibility: Support for Enterprise Architect system modelling tool including helper tools and Add-Ins, covering 1st and 2nd level support. Apply and articulate Model Based Systems Engineering (MBSE) concepts and viewpoints across project phases Utilize software development tools, with a focus on code review applications, to enhance collaborative development and code quality (Adopt DevOps) Maintain awareness and support organizational compliance with GDPR requirements and ISO 27001 information security standards Support the implementation of ISO 13485:2016 and 21CFR requirements for quality management systems, particularly relevant to medical device software Support end-users by addressing their technical issues, troubleshooting, and providing timely resolutions related to ALM tools and associated platforms. Contribute to continuous process improvement. Skills : Mandatory : Knowledge of ALM tools, and requirements management tools like Polarion, IBM Doors Next Gen (DNG), as well as modelling tools such as Magic Draw, IBM Rhapsody, and Enterprise Architect. Exhibit strong proficiency in Azure DevOps, including Kanban board utilization, effective demand management, and product backlog prioritization. Understanding of ISO 27001 information security standards, ISO 13485:2016 and 21CFR requirements for quality management systems, particularly relevant to medical device software. Optional : Understanding of Cybersecurity concepts as per ISO Standards are highly recommended & Ability to handle vulnerable items related to Application layer is preferred. Passion for exploring new tools and technologies with quick learning skills. Ability to understand user needs and support them with efficient collaboration and communication skills. Awareness on Medical Imaging domain and/or Clinical Workflow knowledge will be an added advantage

Key Deliverables: Define the vision, roadmap, and compliance-focused features for Electronic Device History Record (EDHR) platforms. Translate regulatory frameworks (21 CFR Part 820, EU MDR, ISO 13485) into digital product specifications. Lead integration of EDHR with MES, PLM, and QMS systems in medical device manufacturing environments. Support technical pre-sales, audits, and validations to ensure adherence to regulatory standards. Role Responsibilities: Act as SME for global medical device manufacturing compliance (DHF, DHR, MDR). Prioritize and manage product backlog aligned with regulatory demands and business value. Engage with cross-functional teams to ensure agile delivery of validated digital solutions. Drive continuous improvement and regulatory readiness through digital transformation initiatives.

Conducts routine analysis of raw materials, in-process and finished goods under supervision and according to Standard Operating Procedures (SOPs) and Compiles data for documentation of test procedures and prepares reports. Write or revise standard quality control operating procedures and supply quality control data necessary for regulatory submissions. Participates and performs investigation with respect to QC testing performed. Ensure that lab cleanliness and safety standards are maintained. The essential requirements of the job include: Bachelor s degree with 4+ years or Master s with 2 years of related experience. Good communication skills (verbal / written / presentation / relationship building) with ability to work collaboratively. It would be a plus if you also possess previous experience in: Handled Flow cytometer Handled HPLC Handled QMS like Change controls, Deviations, CAPA.

Department Quality Location Thane Work Experience Minimum 3 5 years of experience in Quality Management, preferably in the medical device industry. Key Responsibilities: ISO 13485 Implementation: Lead and manage the implementation of ISO 13485 across all relevant departments. Develop and document QMS processes, procedures, and work instructions. Establish a project plan with milestones and timelines for ISO certification. Quality System Management: Ensure ongoing compliance with ISO 13485 and applicable regulatory requirements (e.g., EU MDR, FDA 21 CFR Part 820 if relevant). Coordinate Management Review meetings and Internal Quality Audits. Lead Corrective and Preventive Action (CAPA) processes. Training Awareness: Train employees on ISO 13485 requirements and QMS procedures. Promote quality awareness and ensure employee engagement in the QMS. Documentation Records Control: Manage and maintain quality documentation including Quality Manual, SOPs, Work Instructions, and Records. Establish document control and record retention systems. Audit Management: Prepare for and coordinate external certification audits. Lead internal audits and support audit readiness at all times. Supplier and Risk Management: Evaluate and monitor suppliers as per ISO 13485 requirements. Support risk management processes (in alignment with ISO 14971). Qualifications Experience: Bachelor s degree in Engineering, Life Sciences, Quality, or related field. Minimum 3 5 years of experience in Quality Management, preferably in the medical device industry. Proven experience implementing ISO 13485. Certification in ISO 13485 Lead Auditor (preferred). Familiarity with medical device regulatory requirements (FDA, CE, etc.). Skills Required: Strong knowledge of ISO 13485 and QMS principles. Project management and leadership capabilities. Excellent documentation and communication skills. Problem-solving and analytical thinking. Ability to work cross-functionally with departments like RD, Manufacturing, and Regulatory Affairs.

Job Title Systems Engineer Job Description Emergency Care Business: In late January, we announced that Bridgefield Capital signed an agreement to acquire Philips Emergency Care business which includes leading brands and products like HeartStart AEDs, Intrepid and DFM100 monitor defibrillators, Tempus monitor and Tempus ALS systems, and Corsium and ECI informatics solutions. We expect the transaction to close at the end of 2025. With Bridgefield s support and building on our 40+ year legacy of growth and innovation in emergency medical technology, the Emergency Care business will continue passionately pursuing our mission of saving lives, lowering the cost of healthcare, and advancing the science of resuscitation while serving the public access AED, EMS, military, and hospital market segments. Systems Engineer In this role, you have the opportunity to Be an integral part of the Emergency Care and Resuscitation (ECR) R&D team, actively participating in cardiac defibrillator product development. ECR team has a broad product portfolio of advanced life support solutions, automated external defibrillators, monitoring and data management solutions. Our mission is to design, produce, and deliver every solution as if the life of someone we love depends on it. Every day, we empower and enable our customers from clinicians to paramedics, first responders to the everyman to save lives using our innovative, market-leading technology. We are looking for a passionate Systems Engineer to join us as we strengthen our product portfolio, expand our services and solutions, and bring game-changing technology to the market. This team member will be responsible for working collaboratively with a team of cross-functional engineers. Your role: Translation of user and business requirements into product requirements, high-level product design, check, and optimize integration and verification. System decomposition and allocation of derived requirements down to HW/SW element and part level, and related traceability. Trade-off of product/system design specifications and interfaces, determine the feasibility of potential solutions, and lead technical & design reviews. Ensuring full Product Safety Risk Management in a regulation-compliant manner. Managing technological complexity of products in multi-disciplinary settings. Develops products, independently and according to ones own judgement, using the latest technologies and resources, often realizing systems based on unverified specifications. Makes a substantial contribution to the innovation of products and processes. Makes independent choices regarding aspects of the design. Gives reasons for changes in specifications. Formulates assignments in dialogue with the customer or user. Submits ideas for future developments and provides tangible input for Technology roadmaps. Develops partly and sometimes wholly new products, processes, or technologies. Elicits, reviews, and characterizes stakeholder feedback; creates and reviews system-user interaction model with various Systems Engineering related Methods/tools Youre the right fit if: Bachelors in a relevant field, including Electrical, Electronics, or other related science. A minimum of 5 years of experience successfully developing complex medical devices (hardware, software, consumables) Products for acute/emergency care/hospital markets are necessary. Have Systems Engineering certification Hands-on experience in ISO 13485, ISO 14971, ISO 20417, IEC 60601-1, and collateral Hands-on experience in requirements management, including developing, deriving, flow down, tracing, and prioritizing requirements. Hands-on experiences in using Model-Based Systems Engineering (MBSE) Tools of Cameo and similar tools. Experience with conducting cross-discipline feasibility and trade-off studies to evaluate electronic and mechanical performance from subsystem to system level for the issue Analytical and architectural thinking, system view, physical insight, flexibility, and a hands-on mentality to deliver sustainable results and creative solutions. Strong understanding of Controls and Software development process, including Model-based Design approach and Test-Driven design methodologies. Solid understanding of System Verification and Validation test plan/protocols, executing V&V (Verification and Validation) (Verification and Validation) activities, generating and Analyzing test reports. Understanding of global medical device regulatory environments and clearance Effective communication, computer, documentation, presentation, and interpersonal skills are required, as well as the ability to work both independently and as part of a team. Maintains strict confidentiality of sensitive information. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company s facilities. Field roles are most effectively done outside of the company s main facilities, generally at the customers or suppliers locations. This role is an office-based role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we wont stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. Learn more about our business . Discover our rich and exciting history . Learn more about our purpose . If you re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here . #LI-PHILIN

Job Summary: We are seeking a proactive and detail-oriented professional to support and coordinate international business operations. The role will focus on managing export activities, building strong client and distributor relationships, and ensuring seamless execution of global sales and distribution processes for IVD products. Key Responsibilities: Develop and implement export strategies to expand market share in international regions. Conduct market research to identify new opportunities in emerging IVD markets. Identify and target new sales opportunities in global markets for IVD products. Coordinate with international clients, distributors, and sales partners for order processing and delivery timelines. Establish and maintain strong relationships with key international distributors, clients, and partners. Monitor and analyze market trends, competitor activity, and customer feedback to support business decisions. Oversee logistics, compliance, and documentation for international shipments and contracts. Negotiate pricing, terms, and agreements with international clients. Ensure timely delivery and provide after-sales support to customers across various countries. Collaborate with internal teams (R&D, Marketing, and Production) to ensure customer requirements are effectively met. Oversee logistics, export & import documentation , and compliance for international shipments and contracts. Willingness to travel as per business requirements. Qualifications & Skills: Bachelors degree in Business Administration, International Trade, Life Sciences, or related field (MBA preferred). 35 years of experience in international sales, export coordination, or business development (IVD/Healthcare industry preferred). Strong knowledge of exportimport documentation, regulations, and compliance . Working knowledge of ISO 13485 (Quality Management System for Medical Devices) . Excellent communication and negotiation skills with cross-cultural awareness. Ability to multitask, prioritize, and manage timelines effectively. Proficiency in MS Office and ERP/CRM tools. Interested candidates may share their updated CV at hr3@athenesedx.com or WhatsApp us at 7338869266

A Day in the Life Role Summary The QARA Director for India will be responsible for leading a team supporting Quality Assurance and Regulatory Affairs activities in India. This leadership role is responsible for developing and executing regulatory strategies and maintaining quality related activities and systems to ensure compliance with Indian and international medical device regulations (e.g. CDSCO, ISO 13485/Indian GMP, US FDA, EU MDR). The QA/RA Director will oversee product registrations, audits, quality assurance programs, and act as the primary liaison with regulatory bodies. The QA/RA Director serves as a member of the leadership team for India and plays a critical role in strategic decision-making, influencing business performance, and driving continuous improvement in quality and regulatory processes. Key Responsibilities Lead Quality Assurance and Regulatory Affairs (QA/RA) activities in India, ensuring compliance with global and regional requirements. Develop and implement regulatory strategies for India to ensure timely submission and approval of product registrations with CDSCO and other authorities. Navigate a complex matrix environment, collaborating with commercial, supply chain, legal, and global QA/RA teams. Partner with cross functional teams to manage licensing, submissions, renewals, inspections, post-market surveillance, and regulatory intelligence. Translate regulations, requirements, and corporate guidelines into effective business processes and procedures; stay abreast of evolving regulations and regulator expectations. Lead the development and strengthening of relationships with regulators and relevant industry organizations. Lead the development and maintenance of the Quality Management System (QMS) in compliance with ISO 13485 and the Indian regulatory requirements, including managing internal and external audits. Develop and maintain a quality strategy and plan for India in alignment with enterprise-wide quality objectives and KPIs. Assume the role of Management Representative for the QMS and oversee and manage QMS processes e.g. CAPA, FCA, complaint handling, supplier and distributor management etc. Drive continuous improvement initiatives and leverage shared services support to drive efficiencies. Provide leadership, coaching, and mentorship to the QA/RA team to build leadership capabilities and foster a culture of quality, compliance, and operational excellence. Qualifications & Experience Minimum of 10-12 years of progressive experience in Quality Assurance and Regulatory Affairs, preferably in the healthcare industry and ideally within the MedTech sector. Strong understanding of the Indian Medical Device Rules (IMDR) under Drugs & Cosmetics Act 1940 and global regulatory frameworks. Proven leadership in managing audits and regulatory submissions (ideally with CDSCO). Strong collaboration and communication skills to influence effectively in a matrixed environment. Proven strategic thinking balancing immediate compliance with long-term capability building. Bachelor s or Master s degree in Life Sciences, Engineering, or related field preferable. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).