Bio Medical Engineer
- No. of Openings 1
- Industry Retail and Trading
- Category Health/Medical/Pharmaceuticals
- Location Hariyali Marg 10, Chakupat, Lalitpur, Lalitpur District
- Job Level Mid Level
- Salary NRS (40K-50K) Monthly (Negotiable)
- Education Level Bachelors
- Desired Candidate Both(Female, Male)
- Experience 3 + years
- Expiry date Dec 01, 2024 (10 days left)
- Vehicle License Yes (Preferred)
- Two/Four Wheeler Require TWO-WHEELER
- Skills Designing, Health & Safety, ISO Compliance, Laboratory Testing Techniques
Job Description
Job Overview:
We are looking for a talented and dedicated Biomedical Engineer to join our team and support the design, development, and maintenance of medical devices and healthcare technology. The ideal candidate will have a strong background in engineering principles as applied to the biomedical field, along with a passion for improving patient care through innovative and safe medical technologies. The Biomedical Engineer will be involved in the entire lifecycle of medical devices, from conception and design to testing, implementation, and ongoing maintenance.
Key Responsibilities:
Design & Development:
- Design and develop medical devices, equipment, and systems, ensuring compliance with regulatory standards (FDA, ISO, etc.).
- Work with multidisciplinary teams (including physicians, technicians, and other engineers) to create innovative solutions to healthcare challenges.
- Develop prototypes, evaluate design specifications, and assess the feasibility of new products.
- Perform software and hardware integration for medical devices to ensure compatibility and functionality.
Testing & Validation:
- Conduct rigorous testing and validation of medical equipment to ensure safety, quality, and performance standards are met.
- Prepare and execute test protocols to verify the performance and reliability of devices and equipment.
- Analyze and interpret test results, make design improvements as necessary, and prepare documentation for regulatory compliance.
- Perform failure analysis and root cause analysis for equipment malfunctions and make necessary design modifications.
Regulatory Compliance & Documentation:
- Ensure that designs, modifications, and innovations comply with local and international regulatory requirements (FDA, CE, etc.).
- Prepare and review technical documentation, including product specifications, user manuals, and regulatory submissions.
- Stay current with changes in biomedical regulations, standards, and best practices.
Project Management:
- Coordinate and manage multiple projects related to product design, testing, and implementation.
- Monitor project timelines, budgets, and deliverables to ensure successful completion of projects within scope and schedule.
- Collaborate with cross-functional teams including clinical staff, regulatory affairs, and quality control teams.
Maintenance & Support:
- Provide technical support and troubleshooting expertise for medical equipment, ensuring devices are operating efficiently.
- Collaborate with hospital/clinic staff to ensure proper installation, calibration, and maintenance of medical equipment.
- Develop and execute maintenance schedules and ensure optimal functionality and reliability of healthcare technologies.
Research & Innovation:
- Conduct research and development to drive innovation in medical technologies and improve existing products.
- Evaluate emerging biomedical technologies, tools, and techniques, and recommend adoption or integration where applicable.
Training & Education:
- Train medical personnel and healthcare professionals on the safe use and operation of medical devices.
- Provide technical guidance on device maintenance, troubleshooting, and safety procedures.
Job Specification
Education & Experience:
- Bachelor’s or Master’s degree in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or a related field.
- 2-5 years of experience in biomedical engineering, with a focus on medical device design, testing, or support (depending on the level of the role).
- Knowledge and experience with FDA regulations (21 CFR Part 820), ISO 13485, IEC standards, and other healthcare industry standards.
Skills & Knowledge:
- Strong knowledge of medical device design, including both hardware and software aspects.
- Familiarity with medical device development tools (e.g., CAD software, simulation tools, programming languages).
- Experience with testing, validation, and verification of medical devices and equipment.
- Strong problem-solving skills with the ability to troubleshoot technical issues and optimize device performance.
- Ability to analyze and interpret data from tests and experiments to improve device designs.
- Excellent communication and teamwork skills, with the ability to collaborate effectively with cross-functional teams.
- Proficiency in project management and the ability to handle multiple tasks simultaneously.
Certifications (optional but preferred):
- Certification in Biomedical Engineering (e.g., Certified Biomedical Equipment Technician [CBET] or similar).
- Knowledge of ISO 13485 and FDA Quality System Regulations (QSR).
Physical Requirements:
- Ability to lift and carry medical equipment up to [insert weight].
- Ability to work in a laboratory or clinical environment, including the potential for exposure to medical equipment and biological hazards.
- Some travel may be required for project installations, repairs, or client meetings.
Working Conditions:
- Work is conducted primarily in a healthcare facility, laboratory, or office setting.
- Occasional fieldwork in hospitals or clinics for installations, troubleshooting, and support.
- Full-time position, with the possibility of extended hours depending on project deadlines or urgent device issues.
- Must be able to adapt to an evolving environment and meet demands of regulatory and compliance standards.
About Company
Seren Path Trading Company Pvt Ltd is a dynamic and diversified investment company dedicated to driving innovation and growth in multiple sectors. Our portfolio spans across information technology, trading, and product development, offering a wide range of services and solutions that cater to the ever-evolving needs of global markets. At Seren Path, we are committed to building value through strategic investments and forward-thinking initiatives that foster sustainable business growth.