Senior Process Engineer – Medical Devices

3 weeks ago

Chennai, Tamil Nadu, India Tek Support Full time

Job Title: Senior Process Engineer – Medical Devices

Location: Chennai, IND

Employment type: Part-time

Job Summary:

We are seeking a highly experienced Process Engineer Trainer with over 10 years of expertise in the medical device industry. The ideal candidate will be responsible for developing, optimizing, and sustaining robust manufacturing processes that ensure product quality, regulatory compliance, and operational efficiency. This role requires strong technical knowledge, leadership skills, and the ability to collaborate cross-functionally to support new product introductions, continuous improvement initiatives, and large-scale manufacturing operations.

Key Responsibilities:

  • Lead the design, development, and validation of manufacturing processes for medical devices in compliance with FDA, ISO 13485, and GMP regulations.
  • Drive process improvements to enhance product quality, reduce cost, and improve efficiency using Lean and Six Sigma methodologies.
  • Support New Product Introduction (NPI) by developing scalable and validated manufacturing processes from concept through commercialization.
  • Collaborate with R&D, Quality, and Operations teams to ensure seamless technology transfer.
  • Lead root cause investigations, implement CAPAs, and ensure corrective actions are effective and sustainable.
  • Develop and maintain process documentation, including work instructions, PFMEA, process flow diagrams, and control plans.
  • Provide technical mentorship to junior engineers and manufacturing teams.
  • Manage and support equipment selection, installation, qualification (IQ/OQ/PQ), and maintenance strategies.
  • Ensure compliance with industry standards, safety regulations, and regulatory requirements across all processes.
  • Lead cross-functional projects focusing on yield improvement, scrap reduction, and cycle time optimization.

Qualifications & Experience:

  • Bachelor's or Master's degree in Mechanical, Biomedical, Industrial, Chemical, or related Engineering field.
  • 10+ years of proven process engineering experience in the medical device industry.
  • Strong knowledge of ISO 13485, FDA 21 CFR Part 11/Part 820, and GMP requirements.
  • Hands-on experience with process validation (IQ, OQ, PQ), equipment qualification, and test method validation.
  • Expertise in Lean Manufacturing, Six Sigma, DOE, and statistical analysis tools.
  • Proven track record in new product introduction, process scale-up, and technology transfer.
  • Strong problem-solving skills with experience in root cause analysis and risk management.
  • Excellent communication, leadership, and cross-functional collaboration skills.

Preferred Skills:

  • Six Sigma Green/Black Belt certification.
  • Experience with automated manufacturing systems, robotics, or advanced manufacturing technologies.
  • Knowledge of polymer processing, assembly techniques, or packaging processes for medical devices.
  • Familiarity with software tools such as Minitab, SolidWorks, or similar engineering applications.

  • Senior Process Engineer – Medical Devices

    4 weeks ago

    Chennai, Tamil Nadu, India Tek Support Full time

    Job Title: Senior Process Engineer – Medical Devices Location: Chennai, IND Employment type: Part-time Job Summary: We are seeking a highly experienced Process Engineer Trainer with over 10 years of expertise in the medical device industry. The ideal candidate will be responsible for developing, optimizing, and sustaining robust manufacturing...

  • Senior Medical Device Developer

    2 weeks ago

    Chennai, Tamil Nadu, India beBeeBiomedicalEngineer Full time ₹ 15,00,000 - ₹ 20,00,000

    Job Title: Senior Biomedical EngineerKey Responsibilities:Design and development of medical devices, ensuring compliance with regulatory standards, safety requirements, and usability guidelines.Lead project management, including setting milestones, allocating resources, coordinating teams, and ensuring timely delivery of high-quality solutions.Technical...

  • Senior Device Development Engineer

    2 weeks ago

    Chennai, Tamil Nadu, India beBeeDevice Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

    Job Title: Senior Device Development EngineerThe role involves leading the development of Meter Dose Inhaler devices, collaborating with manufacturers to select suitable components and ensuring design verification meets user requirements.Candidates will be responsible for developing test methods, testing, validation, and in-silico clinical simulations...

  • Senior Medical Device Implementation Specialist

    2 weeks ago

    Chennai, Tamil Nadu, India beBeeBiomedicalEngineer Full time ₹ 15,00,000 - ₹ 25,00,000

    Job SummaryAre you a skilled Biomedical Engineer with experience in eQMS implementation? We are seeking a professional to collaborate with medical device and healthcare companies, deploy eQMS solutions, and provide clinical application support.The ideal candidate will have a Bachelor's or Master's degree in Biomedical Engineering, Clinical Engineering,...

  • Medical Device Specialist

    2 weeks ago

    Chennai, Tamil Nadu, India beBeeBiomedical Full time ₹ 1,00,000 - ₹ 1,50,000

    About the RoleWe are seeking a highly skilled Biomedical/Service Technician to oversee medical device turnaround at our facility.Key ResponsibilitiesPerform disinfection and cleaning of medical devices as per standardized operating procedures (SOPs).Inspect devices for functional issues after patient usage.Replace components and consumable parts where...

  • Medical Device Specialist

    2 weeks ago

    Chennai, Tamil Nadu, India beBeeBiomedical Full time ₹ 8,00,000 - ₹ 15,00,000

    Job OverviewWe are seeking a highly skilled Medical Device Specialist to join our team. As a key member of our technical staff, you will be responsible for ensuring the seamless performance of our cutting-edge medical equipment.Main Responsibilities:- Installation, calibration, and maintenance of medical devices- Troubleshooting issues and providing prompt...

  • Cybersecurity Expertise: Medical Devices

    2 weeks ago

    Chennai, Tamil Nadu, India beBeeSecurity Full time ₹ 1,00,00,000 - ₹ 1,50,00,000

    Job Title:Product Security Engineering LeaderWe are seeking a Product Security Engineering Leader to drive the development, implementation, and monitoring of security solutions for our cardiac medical devices and infrastructure.This role requires a strategic thinker with strong leadership skills to drive product security initiatives, ensure compliance with...

  • Senior Cyber Security Specialist

    2 weeks ago

    Chennai, Tamil Nadu, India beBeeCybersecurity Full time ₹ 1,25,00,000 - ₹ 1,99,99,999

    Job Overview:The Cyber Security Assessment role involves monitoring and evaluating cybersecurity threats, vulnerabilities, and incidents impacting released medical devices.This includes leading post-market security investigations and coordinating vulnerability response and remediation activities to ensure the safety of patients and maintain regulatory...

  • Design Innovator for Medical Devices

    1 week ago

    Chennai, Tamil Nadu, India beBeeMechanicalEngineering Full time ₹ 15,00,000 - ₹ 25,00,000

    Medical Design Engineer Job DescriptionAbout This Role:We are seeking a skilled Mechanical Design Engineer to join our team. As a key member of our engineering department, you will play a crucial role in the design and development of medical laboratory instruments and appliances.You will work on new product development (NPD) and sustenance projects for...

  • Medical Devices and Equipment Sales

    1 week ago

    Chennai, Tamil Nadu, India ABABIL HEALTHCARE Full time ₹ 5,00,000 - ₹ 8,00,000 per year

    We are HiringMedical Equipment & Devices Sales RepresentativeContact: Nithish (HR Greetings from Ababil Healthcare Pvt LtdWe are currently hiring Sales Engineers for our Medical Equipment & Devices division. If you have a background in medical device sales or are a recent Biomedical graduate eager to begin a career in this exciting field, we encourage you...