Sr. Biomedical Engineer-Medical Devices

B L LIFE SCIENCES PVT LTD

2 - 6 years

4 - 6 Lacs

greater noida

Posted:1 week ago| Platform: GlassDoor logo

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Skills Required

autocad design dfmea risk analysis development documentation mdr manufacturing drive verification planning support evaluation solidworks data report writing

Work Mode

On-site

Job Type

Full Time

Job Description

Minimum 2 to 6 years of experience is required in Biomedical Engineer profile with Medical Devices industry exposure only.
Should have the technical skills like Solid works, Autocad, ISO 13485, Design control document, DFMEA, Risk analysis, Design validation, Plastic, Injection Molding etc
Bachelor degree in Biomedical is mandatory
Able to work in design and development of single use and implantable Class III medical devices
Prepare & maintain Design History File (DHF) and technical documentation aligned with ISO 13485, MDR 2017/745, & FDA 21 CFR 820
Collaborate with cross funcational teams including Regulatory, QA, RA & Manufacturing for project alignment
Drive product verification and validation (V&V) planning and execution
Support clinical evaluation and post market surveillance requirement for implantable devices
Strong understanding of ISO 13485, ISO 14971, IEC 60601, & MDR/FDA regulations
Proficieny in Solidworks, Technical documentation tools
Strong data analysis and technical report writing skills

Job Types: Full-time, Permanent

Pay: ₹35,000.00 - ₹50,000.00 per month

Benefits:

Health insurance
Provident Fund

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