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Medical Device Innovation Specialist
1 week ago
We are seeking an experienced Product Development Engineer to join our medical device team. In this role, you will be responsible for leading product development activities from design and prototyping to testing, validation, and market launch.
You will work closely with cross-functional teams to ensure smooth and compliant product development, focusing on patient outcomes and regulatory standards.
Key Responsibilities:- Develop and implement product strategies and technical requirements aligned with business goals.
- Collaborate with Operations, QA/RA, Technical Support, and Commercial teams to ensure effective product development.
- Design and develop embedded systems, firmware, and software to support fully integrated device functionality.
- Conduct risk assessments and implement risk management strategies.
- Optimize designs for manufacturability, scalability, and performance.
- Manage the product development lifecycle and ensure adherence to regulatory and quality requirements.
- Participate in design reviews and prototype evaluations, providing technical guidance.
- Troubleshoot and resolve product issues during development and post-market stages.
To succeed in this role, you will require:
- A degree in Engineering (Biomedical, Mechanical, Electrical, or a related discipline).
- Minimum of 5 years' experience in product development, preferably in the medical device sector or a closely related field.
- Strong experience with embedded systems, firmware, and software development.
- Proven background in taking medical devices from concept to market launch.
- Solid understanding of design controls, validation, and regulatory compliance.
- Proficiency in hardware and software product design, prototyping, and testing.
- Knowledge of mechanical engineering principles, manufacturing processes, and materials.
- Familiarity with risk management techniques and regulatory documentation practices.
- Skills in CAD tools, programming languages, and embedded platforms.
TN Ireland offers a dynamic and innovative work environment with opportunities for professional growth and development. Our team is passionate about delivering high-quality medical devices that improve patient outcomes.