Senior Biomedical Engineer

Park Group is looking for Senior Biomedical Engineer to join our dynamic team and embark on a rewarding career journey As a Senior Biomedical Engineer, your role is to apply engineering principles and medical knowledge to design, develop, and maintain medical devices and equipment

You will be responsible for ensuring the safety, effectiveness, and regulatory compliance of medical devices

Here are the key responsibilities and tasks typically associated with the position of a Senior Biomedical Engineer:Medical Device Design and Development: Design and develop innovative medical devices and equipment, considering user needs, functionality, and safety

Collaborate with cross-functional teams, including clinicians, researchers, and manufacturing personnel, to translate requirements into viable product designs

Testing and Validation: Conduct testing and validation of medical devices to ensure compliance with regulatory standards and performance requirements

Perform risk assessments and reliability testing to ensure product safety and reliability

Quality Assurance and Regulatory Compliance: Ensure compliance with relevant regulatory standards, such as FDA regulations or international standards like ISO

Develop and implement quality management systems and processes to ensure adherence to quality standards throughout the product lifecycle

Troubleshooting and Maintenance: Identify and resolve technical issues with medical devices and equipment

Conduct root cause analysis and implement corrective actions to address equipment malfunctions or failures

Develop and maintain maintenance schedules and protocols to ensure proper functioning of medical devices

Equipment Installation and Training: Install and configure medical devices and equipment in healthcare facilities

Provide training and support to healthcare professionals on the safe and effective use of medical devices

Product Documentation and Reporting: Prepare and maintain documentation, including technical specifications, design documents, testing reports, and user manuals

Create and maintain accurate records of design changes, test results, and equipment maintenance

Collaboration and Project Management: Collaborate with interdisciplinary teams, including engineers, clinicians, and researchers, to develop and execute projects

Manage project timelines, budgets, and resources to ensure successful project completion

Research and Innovation: Stay updated on the latest advancements in biomedical engineering, medical device technologies, and regulatory requirements

Participate in research activities to explore new technologies and contribute to product innovation

Vendor and Supplier Management: Evaluate and select vendors and suppliers for medical device components and materials

Manage relationships with suppliers and oversee the procurement of components to meet project requirements

Continuous Improvement and Risk Management: Identify areas for process improvement and implement best practices in biomedical engineering

Conduct risk assessments to identify potential hazards associated with medical devices and implement risk mitigation strategies

Requirements:Bachelor's degree in biomedical engineering or a related field

Master's degree or higher preferred

Proven experience as a Biomedical Engineer, preferably in a senior or lead role

Strong knowledge of biomedical engineering principles, medical device design, and regulations

Proficiency in using computer-aided design (CAD) software for product design and development

Understanding of medical device standards and regulations, such as FDA regulations, ISO , or IEC 00

Experience in conducting risk assessments and implementing risk mitigation strategies

Strong analytical and problem-solving skills, with attention to detail

Excellent communication and interpersonal skills to work effectively in interdisciplinary teams and collaborate with stakeholders

Familiarity with quality management systems and processes, such as design controls, verification, and validation

Knowledge of medical device manufacturing processes and quality assurance

Project management skills, including the ability to manage timelines, budgets, and resources

Ability to work independently and prioritize tasks in a dynamic environment

Strong commitment to patient safety, product quality, and regulatory compliance

Professional certifications in biomedical engineering or quality management (preferred)

As a Senior Biomedical Engineer, you play a critical role in the design, development, and maintenance of medical devices and equipment

Your expertise in biomedical engineering, regulatory compliance, and quality assurance contributes to the safety, effectiveness, and reliability of medical devices, ultimately improving patient care and outcomes