Auxein Medical

Site identification Confirming availability of implants at site Site staff training, patient information sheet, consent form, trial master file, product description, logs/ source document, Clinical trial document Arrangement of demonstration Required Candidate profile Any Medical/ Biomedical or related field graduate with Min. 5 years of relevant experience, currently working as a CRA with Medical Device industry, Excellent communication and pleasing personality

Regulatory Strategy & Compliance – US FDA, EU MDR, CDSCO Documentation & Regulatory Submissions Regulatory Monitoring & Reporting UDI Submission – GUDID / EUDAMED Regulatory Audits, Inspections, CAPAs & NCs Closure Required Candidate profile BE/BTech in Mechanical, Biomedical, Biotech, or related fields Min 2 years of exp. in RA for medical devices Knowledge of U.S. FDA, EU MDR, CDSCO regulations RAC/GATE certification is a plus

Responsibilities Regulatory Strategy & Compliance – US FDA, EU MDR, CDSCO Documentation & Regulatory Submissions Regulatory Monitoring & Reporting UDI Submission – GUDID / EUDAMED Regulatory Audits, Inspections, CAPAs & NCs Closure Qualifications BE/BTech in Mechanical, Biomedical, Biotech, or related fields Min 2 years of exp. in RA for medical devices Knowledge of U.S. FDA, EU MDR, CDSCO regulations RAC/GATE certification is a plus Show more Show less

In-house repairs of power tools and their attachments. Regular interaction with customers to understand their needs and recommend the right capital/ consumable products and services of Auxein Medical Participate in training for improving operations Required Candidate profile 2 or more years of exp. with relevant capital products & technology, knowledge about power tools products/surgical procedures. Skilled for repairs of power tools, Maintaining data, reports, inventory.

Quality Inspection, Quality Control, Continuous improvement Implementation GD&T measurements Stack-up analysis based on DFMA Develop & monitor FMEA, pFMEA, Control Plans, NCRs, CAPAs, Calibration reports, knowledge of CMM Machines and Team handling Required Candidate profile BE/ B.Tech- Mechanical Min. 10 yrs exp of Quality Control in Medical Devices/Automotive Industry Collaborate with team and cross-functional partners Active involvement in complaint handling Team KPIs

Design, develop & document components 2D/ 3D drawings Create, analyze, & test product designs Conversant & apply DFM/ DFMA Optimize the application of GD&T Manage team of highly fast paced 20+ Design Engineers with sense of ownership & responsibility Required Candidate profile BTech Mech., 15+ Yrs exp in Design & Development in Medical Devices/ Aerospace. Sound knowledge of Product design, 2D and 3D drawings, DFM, DFMA, Design Verification and Design Validation (ISO 13485).

Microbiological testing, monitoring & sterility assurance, Initiate CAPA, Generate & execute microbial method validation protocols/report, Microbiology procedures, validations, records including writing, routing, approval for Medical Device Industry. Required Candidate profile BSc/ MSc in Microbiology with 3+ year exp. as a Microbiologist in a medical device company. Hands-on with microbiology standards including AAMI ST72, ISO 11737, ISO 14644, ISO 11137, ISO 11135, USP.

Communicate effectively with International Clients/ Customers. Prepare all export documents such as Quotations, Performa Invoice, PO, Labelling & Marking, Commercial Invoice and Packing list etc. Pre-dispatch inspections as per client requirements. Required Candidate profile Graduate/ MBA, Min.2+ yrs exp in Exports in Medical Device or Health Care or any manufacturing industry. Hands-on SAP/ ERP and Advance Excel. Excellent communication and interpersonal skills.

Brief About the Role: The Head- Design & Development will manage a team of 15+ highly experience Design Engineers and work on product development of variety of Accessories, Instruments and Implants. The successful candidate must excel in a fast-paced team environment, and be capable of creative problem solving, when faced with the time pressures and design constraints typical of product development. He or she must have a strong sense of ownership, shared responsibility, commitment to high product quality and be comfortable in collaborating across organizational boundaries. Projects will include a mix of new product development, product improvements, cost savings and manufacturing improvements to enable significant volume growth. Roles and Responsibilities: 1. Design, develop and document components and assemblies for surgical system accessories:  Create product functional and design specifications.  Create, analyze, and test product designs and their components.  Research, understand and design to relevant product specific standards.  Develop, implement, test, and document solutions that meet clinical, functional and product requirements.  Conversant and apply Design for Manufacturing (DFM) and Design for Manufacturing and Assembly(DFMA) concepts.  Optimize the application of GD&T to a feasible DFM, without compromising the engineering requirements to obtain a safe and effective device.  Identification and right selection of materials, suitable for sterilization processes and bio-compatibility.  Support and participate in clinical and human-factor evaluations for new designs or design changes to ensure positive user experiences. 2. Provide mechanical engineering expertise to support continuous production of high-quality surgical accessories to our customers:  Collaborate with the cross functional team to facilitate effective transfer of designs into production.  Work within multi-disciplinary teams to define requirements for new and current designs.  Develop mechanical assemblies, with careful consideration for key functions and safety, while designing for manufacturing-ability, reliability, and cost.  Develop components and product mechanical drawings in a regulated environment.  Design the products using the knowledge of various bio-compatible plastics and their processing efficiency, either in injection molding or in machining, thermoset compression molding, etc.  Conduct the Design Verification and Design Validation per ISO 13485.  Develop Design History Files per FDA requirements.  Contribute to the determination of future product release content. 3. Develop 2D and 3D drawings, and the outputs are preserved as hard and soft copies in a controlled manner, as per the QMS of the organization. 4. Provide technical advice and mentoring to other design engineers. 5. Help establish individual and team goals aligned with overall project and company goals. Desired Education, Skills & Competencies:  BE/BTech in Mechanical Engineering preferably with minimum 2 years certification from CIPET or GTTC or NTTF in Injection Mold Design.  Minimum 15 years of medical products design & Development  Hands-on experience in high precision Product Manufacturing & Design Industry will be preferred.  A passion for solving tough technical problems - strong mechanical intuition and persistence to drill down to pinpoint root cause of problems and solving problems using fundamental principles are desired qualities.  Demonstrated ability to think at a systems level, interface between multiple design groups, and negotiate conflicting requirements.  Proven experience with design for assembly, manufacturing, and automation.  Demonstrated knowledge of materials (including all types of plastics, silicons, isoprene) and material properties.  Ability to apply knowledge of engineering materials and component selection criteria to product designs through strong concept development, design analysis, hands-on prototyping, and reliability testing skills.  Proficiency using CAD to design parts and assemblies and to create specification drawings in a PDM environment; Solidworks, AutoCAD and NX strongly preferred.  Comfortable with all phases of the product development lifecycle including design, implementation, debug, verification, qualification, and transfer.  Comfortable with concepts of design input, design output, traceability, and risk analysis.  Ability to communicate effectively and accurately (written and oral) across all levels and functions, including presenting to a technical audience.  Strong desire to mentor junior engineers and Designers. Job Location: Kundli, Sonipat- Haryana.

On-site technical assistance to surgeons, ensuring optimal use of implants/ instruments. Build long-term relationships with doctors, trauma centers, healthcare professionals. Collaborate with marketing team to execute promotional, surgical workshops Required Candidate profile Graduate, with min.1 year exp & sound knowledge of trauma care protocols, orthopaedic surgical techniques, Clinical curiosity, field resilience, people-first mindset, excellent communicator

On-site technical assistance to surgeons, ensuring optimal use of implants/ instruments. Build long-term relationships with doctors, trauma centers, healthcare professionals. Collaborate with marketing team to execute promotional, surgical workshops Required Candidate profile Graduate, with min.1 year exp & sound knowledge of trauma care protocols, orthopaedic surgical techniques, Clinical curiosity, field resilience, people-first mindset, excellent communicator

Prepare all export documents such as Quotations, Performa Invoice, PO, Labelling & Marking, Commercial Invoice and Packing list etc. Pre-dispatch inspections as per client requirements. Coordinate effectively with International Clients/ Customers. Required Candidate profile Graduate/ MBA, Min.2+ yrs exp in Exports in Medical Device or Health Care or any manufacturing industry. Hands-on SAP/ ERP and Advance Excel. Excellent communication and interpersonal skills.

Process Quality, Quality Inspection, Quality Control, Continuous improvement Develop & monitor FMEA, pFMEA, Control Plans, NCRs, CAPA, Calibration reports, GD&T measurements, Stack-up analysis based on DFMA Exp. of testing instruments & Team handling Required Candidate profile BE/ B.Tech- Mechanical Min. 10 yrs exp of Quality Control in Medical Devices/Automotive Industry Collaborate with team and cross-functional partners Active involvement in complaint handling Team KPIs

VMC Programmer, CAM software programming Solid understanding of Haas and Mazak control systems, tooling selection, setup, troubleshooting machining issues Machine setup, tool calibration, and ensuring component quality as per drawing specifications. Required Candidate profile BE/BTech OR Diploma (Mech.), Min. 5 years exp. as a VMC Programmer, CAM programming for highly prcised industry Capable of diagnosing, resolving errors, tooling solutions, spares and consumables.

Coordinate effectively with International Clients/ Customers. Prepare all export documents such as Quotations, Performa Invoice, PO, Labelling & Marking, Commercial Invoice and Packing list etc. Pre-dispatch inspections as per client requirements. Required Candidate profile Graduate/ MBA, Min.2+ yrs exp in Exports in Medical Device or Health Care or any manufacturing industry. Hands-on SAP/ ERP and Advance Excel. Excellent communication and interpersonal skills.

Overall handling of Quality Procedures & Quality Management System (QMS). Handling & Issuance of NCs, CAPA and Change Control. ISO Audits, PDI, BMR, Audit Documentation, Customer Audits Required Candidate profile BE/ Btech/ Diploma- Mechanical Engineering, Min. 1 year exp as Quality Executive/ Engineer in Medical Devices or Automotive Industry. Prior exp of handling Quality Procedures & QMS, CAPA, Audits.

Responsible for IBD & Export Attending global trade shows, exhibitions, medical conferences to expand market reach Coordination with Cross functional teams for timely dispatch Documentation to ensure compliance, Shipment tracking, payment collection Required Candidate profile 8+ years of exp. in international sales/export management, Logistics preferably in the medical device or healthcare sector, Excellent coordination and communication across internal departments.

Brief About the Role: The Head- Design & Development will manage a team of 15+ highly experience Design Engineers and work on product development of variety of Accessories, Instruments and Implants. The successful candidate must excel in a fast-paced team environment, and be capable of creative problem solving, when faced with the time pressures and design constraints typical of product development. He or she must have a strong sense of ownership, shared responsibility, commitment to high product quality and be comfortable in collaborating across organizational boundaries. Projects will include a mix of new product development, product improvements, cost savings and manufacturing improvements to enable significant volume growth. Roles and Responsibilities: 1. Design, develop and document components and assemblies for surgical system accessories:  Create product functional and design specifications.  Create, analyze, and test product designs and their components.  Research, understand and design to relevant product specific standards.  Develop, implement, test, and document solutions that meet clinical, functional and product requirements.  Conversant and apply Design for Manufacturing (DFM) and Design for Manufacturing and Assembly(DFMA) concepts.  Optimize the application of GD&T to a feasible DFM, without compromising the engineering requirements to obtain a safe and effective device.  Identification and right selection of materials, suitable for sterilization processes and bio-compatibility.  Support and participate in clinical and human-factor evaluations for new designs or design changes to ensure positive user experiences. 2. Provide mechanical engineering expertise to support continuous production of high-quality surgical accessories to our customers:  Collaborate with the cross functional team to facilitate effective transfer of designs into production.  Work within multi-disciplinary teams to define requirements for new and current designs.  Develop mechanical assemblies, with careful consideration for key functions and safety, while designing for manufacturing-ability, reliability, and cost.  Develop components and product mechanical drawings in a regulated environment.  Design the products using the knowledge of various bio-compatible plastics and their processing efficiency, either in injection molding or in machining, thermoset compression molding, etc.  Conduct the Design Verification and Design Validation per ISO 13485.  Develop Design History Files per FDA requirements.  Contribute to the determination of future product release content. 3. Develop 2D and 3D drawings, and the outputs are preserved as hard and soft copies in a controlled manner, as per the QMS of the organization. 4. Provide technical advice and mentoring to other design engineers. 5. Help establish individual and team goals aligned with overall project and company goals. Desired Education, Skills & Competencies:  BE/BTech in Mechanical Engineering preferably with minimum 2 years certification from CIPET or GTTC or NTTF in Injection Mold Design.  Minimum 15 years of medical products design & Development  Hands-on experience in high precision Product Manufacturing & Design Industry will be preferred.  A passion for solving tough technical problems - strong mechanical intuition and persistence to drill down to pinpoint root cause of problems and solving problems using fundamental principles are desired qualities.  Demonstrated ability to think at a systems level, interface between multiple design groups, and negotiate conflicting requirements.  Proven experience with design for assembly, manufacturing, and automation.  Demonstrated knowledge of materials (including all types of plastics, silicons, isoprene) and material properties.  Ability to apply knowledge of engineering materials and component selection criteria to product designs through strong concept development, design analysis, hands-on prototyping, and reliability testing skills.  Proficiency using CAD to design parts and assemblies and to create specification drawings in a PDM environment; Solidworks, AutoCAD and NX strongly preferred.  Comfortable with all phases of the product development lifecycle including design, implementation, debug, verification, qualification, and transfer.  Comfortable with concepts of design input, design output, traceability, and risk analysis.  Ability to communicate effectively and accurately (written and oral) across all levels and functions, including presenting to a technical audience.  Strong desire to mentor junior engineers and Designers. Job Location: Kundli, Sonipat- Haryana.

QMS and it's implementation Review and approval of NCs, CAPA, Change Controls, Validation Master Plan, SMF, BMR, BPR, Quality Manual, Vendor qualification. Lead and manage internal/ external audits, QA compliance, continuous improvement, MRM data Required Candidate profile Bachelor’s/Master’s in Mechanical/ Biomedical 10+ years of exp. QA & QMS in the medical devices Strong knowledge of QMS, GMP, regulatory guidelines (ISO, USFDA, CE, WHO),handling audits, QA practices.

Manage the domestic sales team to achieve revenue & growth targets Customer acquisition and manage key accounts Oversee customer care, order processing, billing & receivables Manage logistics, dispatch, invoicing, and compliance Provide MIS reports Required Candidate profile Graduate/MBA with min. 8 years of experience in domestic sales & operations (Medical Device Industry) Strong ERP, Tally/SAP/CRM, logistics, invoicing, GST, backend operations and communication skills