Medical Device Innovation Specialist
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We are seeking a highly skilled and motivated Medical Device Innovation Specialist to join our team. This role is central to the design, development, and optimization of next-generation medical technologies.
This individual will work cross-functionally to bring products from concept through to commercialization, ensuring compliance with regulatory standards and a strong focus on patient outcomes.
* Lead product innovation activities from design and prototyping to testing, validation, and market launch.
* Collaborate with Operations, QA/RA, Technical Support, and Commercial teams to ensure smooth and compliant product development.
* Partner with Product Management to define product strategies and technical requirements aligned with business goals.
* Define design inputs, conduct feasibility studies, and contribute to the development of technical documentation including design history files and technical files.
* Work on embedded systems, firmware, and software development to support fully integrated device functionality.
* Conduct risk assessments and support the implementation of risk management strategies.
* Optimize designs for manufacturability, scalability, and performance.
* Manage the full product development lifecycle and ensure adherence to regulatory and quality requirements.
* Participate in design reviews and prototype evaluations, offering technical guidance across departments.
* Troubleshoot and resolve product issues during both development and post-market stages.
Minimum Qualifications:
* 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 (e.g., FDA, ISO 13485).
* Proficient in both hardware and software product design, prototyping, and testing.
* Knowledge of mechanical engineering principles, manufacturing processes, and materials.
* Familiar with risk management techniques (e.g., FMEA) and regulatory documentation practices.
* Skilled in CAD tools (e.g., SolidWorks, AutoCAD), MATLAB, C/C++, Python, and embedded platforms.
Core Competencies:
* Strong analytical, problem-solving, and decision-making skills.
* Excellent communication skills, both verbal and written.
* Proven ability to work cross-functionally with engineering, regulatory, quality, and commercial teams.
* Highly detail-oriented, proactive, and adaptable with a continuous improvement mindset.