
Senior Medical Device Engineer
4 days ago
Medical Device Engineering Leadership Opportunity
We are seeking a highly skilled and experienced Medical Device Engineer to lead our team in assessing and auditing medical devices. This individual will be responsible for ensuring compliance with international standards.
Main Responsibilities:
- Evaluate medical devices against ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, and their applications.
- Apply risk management principles as per EN ISO 14971 and possess solid knowledge of non-active devices.
- Collaborate with a team of assessors/auditors on sterilization processes.
Necessary Qualifications:
- Minimum 10 years of experience in healthcare products or related fields.
- A minimum of 5 years of experience in quality management is required.
Required Skills:
- Good understanding of regulatory affairs and quality management principles.
- Ability to analyze complex technical data and make informed decisions.
- Excellent communication and interpersonal skills.
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