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Medical Devices Systems Engineer
2 months ago
Join Our Team as a Medical Device Systems Engineer
At OrganOx, we are committed to developing innovative medical devices that save lives. We are seeking a highly skilled Medical Device Systems Engineer to join our dynamic team and contribute to the design and development of new products.
Key Responsibilities- Design and Development: Provide cross-discipline design oversight within the new product development team, contributing to the development and maintenance of system specifications, integration of product subsystems, and development and review of test plans.
- Systems Integration: Lead systems integration across mechanical, software, and electronics teams, ensuring seamless collaboration and effective communication.
- Design Reviews: Lead design reviews, including the compilation of materials for review, to ensure compliance with OrganOx's design and development procedures.
- Verification and Validation: Collaborate with the team to identify, plan, and conduct verification and validation testing, reviewing output reports and leading the implementation of changes based on outcomes.
- Proven Track Record: Proven track record in the design, development, verification, and validation of medical devices or other complex high-integrity products.
- Compliance: Track record of design and development of products compliant with ISO 13485 and ISO 14971 or equivalent standards.
- Manufacturing Experience: Experience of transferring product designs into manufacture.
- Technical Reporting: Strong ability to produce technical reports to a high standard, both in terms of technical content and written English.
- Communication Skills: Effective communication skills and ability to work effectively in a multi-disciplinary team.
- Supplier Management: Proficiency in working effectively with outside suppliers and manufacturers.
- Project Management: Ability to work across multiple projects simultaneously.
- Product Lifecycle Management: Experience of product lifecycle management tools.
- Medical Device Standards: Familiarity with medical device standards, including ISO 60601, 62366, 14971, 10993, and others.
- Education and Experience: Degree in engineering (medical, electronics, mechanical, or other relevant field) or demonstrated experience, and industry experience in medical devices or a similar field.
