Capgemini Technology Services Hiring | Medical Device Development | Bachelor’s Degree in Mechanical Engineering | Exp. – 2 to 6 years |
Position – Medical Device Development
Capgemini Technology Services India Limited
Exp. – 2 to 6 years
Location – Pune, Gandhinagar, Bengaluru
Job description
- Good understanding and hands on experience in ISO 13485:2016 and 21 CFR Part 820
- Good understanding of the Quality & Regulatory requirements of USA, European Union (MDR 2017/745 & MDD 93/42/EEC) is must
- Proficient in Medical Device Development as per the Regulatory Requirements
- Experience in electro-mechanical design, sustenance within medical devices domain
- Ability to create design drawings, 3D models in SolidWorks
- Tolerance stack up analysis
- Proficient in preparing DFMA, assembly instructions
- Experience in identifying applicable standards for packaging, environmental compliance
- Experience in DHF & DMR creation, GSPR and Technical File
- Must possess strong written and verbal communication skills
- Must possess demonstrated ability to handle multiple priorities simultaneously
- Strong Analytical Skills
Qualifications
- Bachelor’s Degree in Mechanical Engineering
- DHF remediation (Design history files)
