# Medical Device R&D Process & Product Design…

> Source: https://confidential.careers/job-detail/medical-device-r-d-process-product-design-associate-99765-mycareernet-indore

# Medical Device R&D Process & Product Design Associate_99765

MyCareernet 

** Indore, India ** Full Time ** Healthcare Jobs ** India ** New

[Apply Now](https://confidential.careers/go/14203570) ** Save 

## Job Description

**Key Skills:** ISO 13485, ISO 14971, IEC 62304, 21 CFR, Design Controls, Risk Management, Traceability Matrix, Medical Device Regulations

**Roles & Responsibilities:**

- Support post-production risk review activities as per defined regulatory schedules
- Coordinate with stakeholders to collect and analyze post-production data for risk assessment
- Prepare and update risk management reports and ensure approval workflow compliance
- Maintain traceability matrices linking design requirements to objective evidence
- Assist design control engineers in documentation and data analysis tasks
- Query internal/external databases and generate reports for R&D and risk teams
- Ensure documentation compliance with medical device regulatory standards
- Support lifecycle documentation across design, development, and post-production phases

**Experience Required:**

- 3-5 years of experience in medical device R&D, risk management, or design control processes
- Experience working in regulated environments (medical device or healthcare products)
- Exposure to post-production risk analysis and reporting activities
- Experience maintaining traceability matrices and design documentation
- Experience working with cross-functional R&D and quality/regulatory teams
- Experience supporting ISO 13485 / ISO 14971 compliance activities
- Experience in data analysis and reporting for engineering/R&D functions
- Exposure to IEC 62304 or similar medical software lifecycle standards is preferred
- Experience working with requirement management or documentation tools is an advantage

**Education:**Any Graduation

Posted August 15, 2026