Product Innovation Engineer
6 days ago
Job Description
This Medical Device Development Specialist position requires a highly skilled and motivated individual to lead product development activities from design and prototyping to testing, validation, and market launch.
The ideal candidate will have a degree in Engineering (Biomedical, Mechanical, Electrical, or a related discipline) and minimum of 5 years' experience in product development, preferably in the medical device sector or a closely related field.
Key Responsibilities Include:
- Collaboration with cross-functional teams to ensure smooth and compliant product development.
- Partnership with Product Management to define product strategies and technical requirements aligned with business goals.
- 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 implement risk management strategies.
Requirements
- 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).
- Proficient in both hardware and software product design, prototyping, and testing.
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.
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