Senior Biomedical Engineer

• Design and Development: Lead the design and development of medical devices and equipment, ensuring compliance with regulatory standards, safety requirements, and usability guidelines
• This includes creating detailed specifications, conducting feasibility studies, and overseeing prototype fabrication and testing
• Project Management: Manage the entire product development lifecycle, including setting project milestones, allocating resources, coordinating cross-functional teams, and ensuring timely delivery of high-quality solutions
• Monitor project progress, identify risks, and implement effective mitigation strategies
• Technical Expertise: Possess in-depth knowledge of biomedical engineering principles and practices, including electronics, instrumentation, mechanics, and materials science
• Stay up to date with the latest advancements in medical technology and contribute to research and development efforts
• Regulatory Compliance: Ensure compliance with applicable regulatory standards and guidelines, such as FDA regulations and international quality standards (eg, ISO 13485)
• Prepare and maintain technical documentation, including design files, risk management files, and regulatory submissions
• Quality Assurance: Develop and implement quality assurance procedures to ensure the safety, reliability, and performance of medical devices
• Conduct risk assessments, perform verification and validation activities, and collaborate with internal teams to address any quality issues or non-conformities
• Collaboration and Communication: Collaborate with cross-functional teams, including physicians, nurses, scientists, and other engineers, to understand their requirements and incorporate their feedback into the design process
• Effectively communicate complex technical concepts to both technical and non-technical stakeholders
• Troubleshooting and Maintenance: Provide technical support and troubleshooting expertise for medical devices, both during development and post-market
• Develop maintenance and calibration protocols to ensure equipment functionality and longevity
• Research and Innovation: Stay abreast of emerging trends and technologies in the field of biomedical engineering
• Identify opportunities for innovation and improvement, conduct research, and propose and implement novel solutions to enhance patient care and clinical outcomes
• Mentoring and Leadership: Provide guidance and mentorship to junior engineers and technicians
• Lead by example, fostering a culture of collaboration, innovation, and continuous learning within the team
• Documentation and Reporting: Prepare technical reports, documentation, and presentations to effectively communicate project progress, findings, and recommendations to management, regulatory authorities, and other stakeholders

Requirements:

• Bachelor's or Master's degree in Biomedical Engineering or a related field (PhD may be preferred for certain positions
• Extensive experience (typically 8+ years) in biomedical engineering, medical device development, or a related field
• Strong knowledge of medical device regulations and standards (eg, FDA, ISO)
• Proficiency in engineering design software and tools (CAD, MATLAB, etc)
• Excellent problem-solving and analytical skills
• Strong communication and interpersonal skills
• Ability to work effectively in multidisciplinary teams
• Attention to detail and commitment to quality and patient safety