
Senior Medical Device Implementation Specialist
6 hours ago
We are seeking a highly skilled Biomedical Engineer to join our team in Surat, India. This is an exciting opportunity for a motivated individual to work on eQMS implementation and contribute to the success of our clients.
As a Biomedical Engineer, you will be responsible for deploying eQMS solutions for medical device and healthcare companies. You will provide training sessions, workshops, and onboarding programs for healthcare professionals and client teams. You will also act as a subject matter expert in compliance standards (ISO 13485, FDA 21 CFR Part 11) and support clinical applications.
Job Responsibilities- Deploy eQMS solutions for medical device and healthcare companies.
- Provide training sessions, workshops, and onboarding programs for healthcare professionals and client teams.
- Act as a subject matter expert in compliance standards (ISO 13485, FDA 21 CFR Part 11).
- Support clinical applications and liaise with hospitals, laboratories, and device manufacturers.
- Gather customer feedback and work closely with product & engineering teams to support feature improvements.
- Support clients during audits, inspections, and compliance reviews.
- Education: Bachelor's or Master's degree in Biomedical Engineering, Clinical Engineering, Biotechnology, or equivalent.
- Experience: Prior exposure to medical devices, hospital equipment, or clinical applications.
- Knowledge of compliance frameworks: ISO 13485, FDA 21 CFR Part 11, GxP, MDR (preferred).
- Ability to train, mentor, and support healthcare professionals with clarity.
- Strong problem-solving mindset and ability to work with cross-functional teams.
- Excellent communication & presentation skills (to engage medical professionals and regulatory staff).
- Analytical and detail-oriented with strong documentation skills.
- Empathy and patience while supporting clinical staff and clients.
- Collaborative mindset to work with diverse stakeholders.
- Adaptability to handle regulatory challenges and evolving customer needs.
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