Medical Devices Systems Engineer

OrganOx is in the process of expanding its engineering capability and is seeking to appoint a Medical Device Systems Engineer to play a key role in the design and development of new products.

 The Medical Device Systems Engineer will have broad experience in the development of medical devices or other complex electromechanical products, from ideation through to product launch. This individual will provide cross-discipline design oversight within the new product development team. This role involves contribution to the development and maintenance of system specifications, integration of the product subsystems, development and review of test plans and will lead risk analysis activities.

 The Medical Device Systems Engineer must possess excellent written and verbal communication skills to document their activities in line with the company Quality Management System, with the ability to plan and report to a standard suitable for regulatory review.

Requirements

Major Responsibilities:

• Ownership of Specifications and Requirements, working with the wider team to ensure requirements are well captured, documented and reviewed

• Leading systems integration across the mechanical, software and electronics teams
• Leading design reviews, including the compilation of materials for review
• Collaborating with the team to identify, plan and conduct verification and validation testing as well as reviewing output reports and leading the implementation of changes based on outcomes
• Working within the quality management system to ensure Ensuring compliance with OrganOx’s design and development procedure

Skills and Qualifications

• Proven track record in the design, development, verification and validation of medical devices or other complex high integrity products
• Track record of design and development of products compliant with ISO 13485 and ISO 14971 or equivalent standards.
• Experience of transferring of product designs into manufacture
• Strong ability to produce Technical Reports to a high standard both in terms of technical content, presentation and written English.
• Effective communication skills and ability to work effectively in a multi-disciplinary team
• Proficiency in working effectively with outside suppliers and manufacturers
• Ability to work across multiple projects simultaneously
• Experience of Product Lifecycle management tools
• Familiarity with medical device standards including ISO 60601, 62366, 14971, 10993 and others.
• Degree in engineering (medical, electronics, mechanical or other relevant field) OR demonstrated experience
• 3+ years industry experience (medical devices or other similar field)

Benefits

• Private Healthcare Plan
• Pension Plans
• Life Assurance
• Leave Package
• Work From Home
• Training & Development
• Employee Assistance Programme - Counseling
• Stock Option Plan