12 Biocompatibility Jobs

As a Research Scientist in Preclinical Development specializing in Biomaterials & Drug Delivery at our company, you will be responsible for supporting the pre-clinical development of a drug delivery system. We are seeking highly motivated candidates with 2-3 years of experience in polymer-based formulations, in vitro/in vivo studies, and analytical characterization. If you are a high-energy, self-driven individual excited to work in a fast-growing startup ecosystem, this role is perfect for you. **Key Responsibilities:** - Formulation development - In-vitro release studies - Biocompatibility and pre-clinical study preparation - Data analysis and documentation - Tech-transfer readiness for GL...

As a skilled Mechanical CAD Engineer specializing in enclosure design for wearable electronics, your role will involve: - Designing mechanical enclosures for various wearable electronic products such as wristbands, patches, medical wearables, IoT devices, etc. utilizing CAD tools like SolidWorks, Creo, Fusion 360, or equivalent. - Collaborating closely with electronics engineers and industrial designers to ensure seamless integration of PCBs, batteries, antennas, and sensors. - Developing ergonomic, lightweight, and durable enclosures suitable for daily wear, ensuring IP-rated sealing for waterproofing and dustproofing, and complying with drop and vibration requirements. - Creating and manag...

Experience : 5.00 + years Salary : Confidential (based on experience) Shift : (GMT+05:30) Asia/Kolkata (IST) Opportunity Type : Hybrid (Chennai) Placement Type : Full time Permanent Position (*Note: This is a requirement for one of Uplers client - Aletha Health) What do you need for this opportunity Must have skills required: Quality Control, Quality Assurance, ISO 13485, ISO 14971, ISO 2859-1, Polymer Testing Aletha Health is Looking for: Role Summary We're seeking a hands-on Senior QA/QC Engineer to build, run, and continually improve our medical device quality system, with a strong focus on plastic components and assemblies. You'll own incoming/in-process/final quality, validation and tes...

Role Overview: As the QC Head, you will be responsible for leading the Quality Control function in medical device manufacturing to ensure that products meet global regulatory, safety, and performance standards. Your role will involve overseeing raw material testing, in-process quality checks, stability studies, validation protocols, and final product release in compliance with applicable regulatory guidelines. Key Responsibilities: - Establish, implement, and maintain QC protocols, SOPs, testing procedures, and specifications. - Ensure batch-wise testing, documentation, and release of raw materials, intermediates, and finished products. - Oversee microbiological and biochemical testing for s...

Role Summary The QC Head will lead the Quality Control function for medical device manufacturing ensuring products meet global regulatory, safety, and performance standards. The role involves oversight of raw material testing, in-process quality checks, stability studies, validation protocols, and final product release as per applicable regulatory guidelines. Key Responsibilities 1. Quality Control Management Establish, implement, and maintain QC protocols, SOPs, testing procedures, and specifications. Ensure batch-wise testing, documentation, and release of raw materials, intermediates, and finished products. Oversee microbiological and biochemical testing relevant to sterile and non-steril...

Role & responsibilities: Solid fundamental understanding on biocompatibility series; ISO 10993 standards, biomaterials, toxicological assessment, extractable and leachable analysis, and biocompatibility assessment methodology. Standards and Regulations Knowledge / Capability - Ability to interpret current Bio/Tox standards, understands impact of external Bio/Tox standards requirements to internal Bio/Tox processes and procedures. Project Knowledge / Capability - Capability (with minimal guidance / support) to provide Bio/Tox related change control & NPC/SPRING project support as well as support / provide guidance to lower-level associates. Product Knowledge / Capability - Advanced knowledge ...

Job Description of Biocompatibility/Toxicological Risk Assessment/Chemical Analyst- Senior Engineer or Tech lead 1. Develop and prepare a biological evaluation plan and report. 2. Perform gap assessments of products by reviewing legacy documentation and evaluating device BOMs to determine the applicability of test data to ISO 10993 standard. 3. Write biological risk assessments to ensure all the relevant end points mentioned in ISO 10993 are met. 4. Participate in the analysis of technical issues and in the development of recommendations for project decisions and actions. 5. Good Knowledge in of EU MDR 2017/745, ISO 13485, and ISO 14971. 6. Well Exposure in Chemical and material characteriza...

Role & responsibilities Lead end-to-end design and industrialisation of disposable drug reservoirs, infusion sets and fluidpath components for wearable delivery devices. Create concept and detailed CAD, drawings and tolerance stacks optimised for highvolume injection moulding and automated assembly; drive DfM/DfA with suppliers. Prototype rapidly and validate to requirements (leak/occlusion/burst, flow resistance, particulate, usability) with documented V&V. Select materials and joining methods (medicalgrade polymers, adhesives, cannulas, membranes) aligned with ISO 10993, ISO 80369 and ISO 11607; consider sterilisation (EtO/gamma) and package validation. Own DHF artefacts and risk analysis ...

As a skilled Mechanical CAD Engineer specializing in enclosure design for wearable electronics, you will play a crucial role in our electronics design company that focuses on developing next-generation wearable products for healthcare and consumer applications. Your main responsibilities will include: - Designing mechanical enclosures for various wearable electronic products such as wristbands, patches, medical wearables, and IoT devices using CAD tools like SolidWorks, Creo, Fusion 360, or equivalent. - Collaborating closely with electronics engineers and industrial designers to ensure the seamless integration of PCBs, batteries, antennas, and sensors. - Developing ergonomic, lightweight, a...

Assist in operating and maintaining biomedical equipment. Conduct routine tests and document results under supervision. Gain knowledge in regulatory standards and safety protocols. Support in troubleshooting technical issues and equipment calibrations. Participate in training sessions for professional development.

Equipment Maintenance and Calibration: Perform scheduled preventive maintenance (PM) inspections on medical equipment according to manufacturer specifications and regulatory requirements. Calibrate and adjust equipment settings to ensure accurate and reliable performance, documenting all maintenance activities and findings. Troubleshooting and Repairs: Diagnose and troubleshoot malfunctions, faults, and performance issues in biomedical equipment, utilizing technical manuals, schematics, and diagnostic tools. Repair or replace defective components, parts, or modules to restore equipment functionality and safety. Safety Inspections and Compliance: Conduct safety inspections and electrical safe...

Job Discretion: JL 5 - Sr Associate role - Electrical or Mechanical Engineering with 5+ years of experience . 3+ relevant years of experience in Design Control of Medical Devices . Life cycle management, making decisions in change management. Change management - Cost reduction, process improvement. Regulatory affairs MDR to EMUDR , follow the regulatory & statutory requirements Work with cross functional teams. Excellent written & verbal communication. Act as project lead – coordinate with different teams - Design Control , MTO, Service, Regulatory Affairs . Team lead experience. Good to have experience in ophthalmology . Consumables and Accessories experience. People with experience in Ster...