Senior Biomedical Engineer

Our client is seeking a highly skilled and experienced Senior Biomedical Engineer to join their innovative research and development team in Nelspruit, Mpumalanga . This role is central to the design, development, testing, and implementation of novel medical devices and healthcare technologies. The ideal candidate will possess a strong foundation in engineering principles, a deep understanding of human physiology, and a proven track record in the medical device industry.

You will be responsible for leading projects from conception to market launch, ensuring compliance with stringent regulatory standards (e.g., FDA, CE). This position demands exceptional problem-solving abilities, a meticulous attention to detail, and a collaborative approach, working closely with clinicians, researchers, and manufacturing teams. We are looking for a technical leader passionate about advancing healthcare solutions and improving patient outcomes through cutting-edge biomedical engineering.

Your expertise will be critical in driving the development of life-saving and life-enhancing medical technologies.

• Lead the design and development of new biomedical devices and healthcare technologies.
• Conduct research and feasibility studies for innovative medical device concepts.
• Develop prototypes and perform rigorous testing to ensure performance, safety, and reliability.
• Collaborate with cross-functional teams, including clinicians, researchers, and regulatory affairs specialists.
• Ensure all designs and development processes comply with relevant industry standards and regulatory requirements (e.g., ISO 13485, FDA regulations).
• Prepare technical documentation, including design specifications, test protocols, and manufacturing transfer documents.
• Troubleshoot and resolve technical issues during product development and post-market phases.
• Mentor junior engineers and provide technical guidance to the R&D team.
• Stay abreast of advancements in biomedical engineering, medical technology, and relevant scientific fields.
• Contribute to intellectual property generation and patent applications.

A Master's degree or PhD in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related field. A minimum of 7 years of progressive experience in the biomedical engineering field, with a focus on medical device design and development. Proven experience in leading R&D projects from concept to commercialization. In-depth knowledge of medical device regulations and quality management systems. Proficiency in CAD software, simulation tools, and relevant engineering design software.

Strong understanding of human anatomy, physiology, and medical device materials. Excellent analytical, problem-solving, and critical thinking skills. Exceptional written and verbal communication skills. Ability to work effectively in a multidisciplinary team environment. Experience with specific medical device technologies (e.g., implants, diagnostic equipment, therapeutic devices) is an advantage.

Our client offers a competitive salary, commensurate with extensive experience and expertise, and a comprehensive benefits package. This role provides a significant opportunity to contribute to impactful innovations in the healthcare sector within Nelspruit . You will be part of a dynamic and research-oriented environment with excellent prospects for professional growth and leadership development.