
Senior Technical Lead for Medical Devices
5 days ago
Job Description
We are seeking an experienced Senior Device Engineer to lead our medical device initiatives. The ideal candidate will have a strong background in medical device development, quality management, and regulatory compliance.
Key Responsibilities:
- Assess and audit medical devices to ensure compliance with relevant regulations.
- Collaborate with cross-functional teams to achieve project goals.
- Develop and implement quality management systems to meet regulatory requirements.
- Conduct risk management assessments using EN ISO 14971.
Requirements:
- At least 10 years of experience in the medical devices industry, including research and development, manufacturing, quality management, or regulatory affairs.
- 5+ years of experience in quality management is essential.
- Strong knowledge of ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, and their application.
- Experience with MDR 2017/745, MDSAP, and IMDR is highly desirable.
Benefits:
The successful candidate will have the opportunity to work on high-profile medical device projects, develop their skills and expertise, and contribute to the growth and success of our organization.
What We Offer:
- A dynamic and supportive work environment.
- Opportunities for professional growth and development.
- A competitive salary and benefits package.
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