Mechanical Engineer

We are seeking a highly skilled Mechanical Engineer with experience in the medical domain to join our team. The ideal candidate will have a strong background in product design, design for manufacturing, finite element analysis (FEA), and a solid understanding of ISO 13485 quality management systems. The successful candidate will play a crucial role in the development of innovative respiratory medical devices, ensuring compliance with regulatory standards and optimising product performance.

Responsibilities

• Collaborate with cross-functional teams to conceptualise, design, and develop respiratory medical devices from initial concept through production.
• Conduct feasibility studies and risk assessments to inform the design process and ensure compliance with regulatory requirements.
• Utilize CAD software to create detailed 3D models and engineering drawings for components and assemblies.
• Perform finite element analysis (FEA) to evaluate structural integrity, thermal performance, and fluid dynamics of medical device designs.
• Apply design for manufacturing (DFM) principles to optimize product manufacturability, cost-effectiveness, and scalability.
• Work closely with suppliers and manufacturing partners to prototype, test, and iterate designs for performance optimization and manufacturability.
• Support the development and maintenance of design control documentation, including design inputs, verification/validation protocols, and risk management files, in accordance with ISO 13485 and other relevant standards.
• Participate in design reviews, risk management meetings, and regulatory submissions to ensure compliance with applicable standards and regulations.
• Stay current with industry trends, best practices, and emerging technologies in medical device design and regulatory compliance.

Qualifications

• Bachelor's degree in Mechanical Engineering or related field; evaluation will be based on skill set.
• 3-5 years of experience in mechanical design and product development within the medical device industry, preferably in the Class 2 Medical devices.
• Excellent problem-solving skills and attention to detail.
• Effective communication and collaboration skills, with the ability to work in cross-functional teams.
• Proven track record of delivering high-quality, innovative medical device designs on time and within budget
• Proficiency in CAD software (e.g., SolidWorks, Fusion 360) for 3D modeling and engineering drawings.
• Strong understanding of finite element analysis (FEA) techniques and software (e.g., ANSYS, Abaqus).
• Experience with design for manufacturing (DFM) principles and practices.
• Familiarity with ISO 13485 quality management system requirements and medical device regulations (e.g., FDA QSR, EU MDR).