
Senior Medical Device Specialist
2 days ago
We are seeking an experienced Biomedical Engineer to join our team in Surat, India. The ideal candidate will have a strong background in medical device and healthcare companies.
- This role involves deploying Orcanos eQMS with medical device and healthcare companies.
- The selected candidate will conduct training sessions, workshops, and onboarding programs for healthcare professionals and client teams.
- This position requires the ability to act as a subject matter expert in compliance standards (ISO 13485, FDA 21 CFR Part 11).
- The successful applicant will provide clinical application support and liaise with hospitals, laboratories, and device manufacturers.
- Gathering customer feedback and working closely with product & engineering teams to support feature improvements is also a key responsibility.
- Supporting clients during audits, inspections, and compliance reviews will be essential.
Key Requirements:
- Education: A 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).
- Able 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).
Desirable Qualifications:
- 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.
Language Requirements:
- Fluency in English (written & spoken) is mandatory.
About the Role:
- This is a fantastic opportunity to work with leading organizations in the medical device industry.
- As a Biomedical Engineer, you will play a critical role in ensuring the quality and safety of medical devices.
- Opportunities for professional growth and development are plentiful.
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