Medical Devices Systems Engineer

OrganOx is expanding its engineering capability and seeking a Medical Device Systems Engineer to play a key role in designing and developing new products. The role involves contributing to system specifications, integrating product subsystems, developing and reviewing test plans, and leading risk analysis activities. The ideal candidate will have broad experience in medical device or complex electromechanical product development, from ideation to product launch. They must possess excellent communication skills for documentation and reporting to regulatory standards.

Key responsibilities include:

• Owning specifications and requirements
• Leading systems integration across mechanical, software, and electronics teams
• Conducting and leading design reviews
• Collaborating on verification and validation testing
• Ensuring compliance with OrganOx's design and development procedures

Required skills and qualifications:

• Proven track record in medical device or complex product development
• Experience with ISO 13485 and ISO 14971 standards
• Ability to transfer product designs into manufacture
• Strong technical report writing skills
• Effective communication and teamwork abilities
• Experience with product lifecycle management tools
• Familiarity with medical device standards (ISO 60601, 62366, 14971, 10993)
• Degree in engineering or demonstrated experience
• 3+ years of industry experience

This role offers an opportunity to work on cutting-edge medical devices in a dynamic, expanding company. The successful candidate will play a crucial role in shaping the future of OrganOx's products while ensuring compliance with industry standards and regulations.