5 13485 Jobs

The Program Manager will be a senior program leader in the PCS (Patient Care Solutions) NPI excellence team in driving initiatives to improve the effectiveness of the NPI excellence and operations functions and interfaces with other functions to provide effective coordination of metrics, dashboards, functional processes, and cross-functional initiative coordination • Responsible for departmental operations planning/execution or is focused on execution of professional activities within a technical discipline. • The job allows modification of procedures and practices covering work as long as the end results meet standards of acceptability (quality, volume, timeliness etc.) • Should have 12+ years of experience working in End-to-End Product life cycle Projects (PRD Life cycle Phases) in Healthcare Industry with Program management experience of at least 5 years • Should have experience working in Systems Engineering • Should have experience in interacting with global Program directors in gathering the data and understanding the Health, Financials, Schedule, Risks & Dependencies of NPI & ATD Programs • Should have experience in Smartsheet for creating the Dashboards and automation of Excel sheets using Macros • Should have knowledge of best practices and Implementing new Processes across the Organization • Should be aware of ISO 13485 & ISO 14971 Standards

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

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)

Engineering degree with minimum 5-10 years experience in LMS & QMS Administration of Quality Management Systems Experience with a learning management system Experience in developing and facilitating training Experience using SharePoint

Bachelors degree in Engineering 8+ years of quality systems experience Experience in Process Development, Validation& MSA, is Mandatory Working knowledge of auditing experience to the FDA Quality System Regulation, ISO 13485, and the MDD