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Medical Devices Systems Engineer
2 months ago
We are seeking a highly skilled Medical Devices Systems Engineer to join our team at Maryland Medical Day Services Llc. As a key member of our product development team, you will play a critical role in the design and development of new medical devices.
The successful candidate will have a strong background in the development of medical devices or other complex electromechanical products, from ideation through to product launch. You will provide cross-discipline design oversight within the new product development team, contributing to the development and maintenance of system specifications, integration of product subsystems, development and review of test plans, and leading risk analysis activities.
Key Responsibilities:
- Design and Development: Ownership of specifications and requirements, working with the wider team to ensure requirements are well captured, documented, and reviewed.
- Systems Integration: Leading systems integration across the mechanical, software, and electronics teams.
- Design Reviews: Leading design reviews, including the compilation of materials for review.
- Verification and Validation: 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.
- Quality Management: Working within the quality management system to ensure compliance with our design and development procedures.
Requirements:
- Proven track record in the design, development, verification, and validation of medical devices or other complex high-integrity products.
- Experience of transferring 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.
- Industry experience in medical devices or other similar fields.
We are committed to creating a diverse and inclusive work environment that values innovation, evidence, integrity, teamwork, respect, and passion. If you are a motivated and experienced professional looking to grow and develop your career, we encourage you to apply.
