Job Summary
We are looking for a skilled Product Engineer – Medical Devices to support the design, development, testing, validation, and improvement of medical device products. The role will work closely with R&D, Quality, Regulatory Affairs, Manufacturing, Clinical, and Supply Chain teams to ensure products meet performance, safety, quality, and regulatory requirements.
Key Responsibilities
- Design and develop new medical device products and components based on product and clinical requirements.
- Convert product requirements into engineering specifications, drawings, prototypes, and design outputs.
- Prepare and maintain BOMs, engineering drawings, specifications, design files, and technical documentation.
- Support the complete product development lifecycle from concept and prototyping through verification, validation, transfer, and commercialization.
- Conduct product testing, verification, validation, reliability testing, and performance evaluation.
- Work with the Quality and Regulatory teams to ensure compliance with applicable medical device standards and regulations.
- Support Design Control activities, including design inputs, outputs, reviews, verification, validation, and design changes.
- Participate in risk management activities, including FMEA and risk analysis.
- Identify product defects, investigate failures, and perform root-cause analysis.
- Implement corrective and preventive engineering improvements.
- Support manufacturing teams during Design Transfer and production scale-up.
- Work with suppliers on component development, technical specifications, qualification, and quality issues.
- Evaluate materials, components, manufacturing processes, and alternative designs.
- Drive product improvements related to performance, reliability, usability, manufacturability, and cost.
- Support engineering change requests, ECO/ECN processes, and product configuration management.
- Analyze field complaints, customer feedback, and product performance data to identify improvement opportunities.
- Prepare technical reports, test protocols, test reports, and other engineering documentation.
- Participate in internal and external audits when required.
- Ensure all product development activities are properly documented and traceable.
Regulatory & Quality Knowledge
Candidate should have exposure to relevant medical device requirements such as:
- ISO 13485 – Quality Management Systems for Medical Devices
- ISO 14971 – Medical Device Risk Management
- IEC 60601, where applicable to electrical medical devices
- Design Control and Design History File (DHF)
- Device Master Record (DMR)
- Verification & Validation (V&V)
- Design Transfer
- CAPA and Non-Conformance
- Change Control / ECO / ECN
- Supplier Qualification
- Regulatory documentation and compliance
Candidate Profile
- Bachelor's/Master's degree in Mechanical, Biomedical, Electronics, Electrical, Mechatronics, or a relevant engineering discipline.
- 2–6 years of experience in medical device product development, R&D, product engineering, or design engineering.
- Experience with medical devices, healthcare products, surgical instruments, implants, diagnostic devices, or related products preferred.
- Good understanding of engineering drawings, CAD, materials, manufacturing processes, and product testing.
- Working knowledge of Design Control, Risk Management, Verification & Validation, and Design Transfer.
- Knowledge of ISO 13485 and ISO 14971 preferred.
- Strong analytical, troubleshooting, documentation, and problem-solving skills.
- Ability to work effectively with cross-functional teams.
- Strong attention to detail and quality mindset.
Preferred Skills
- CAD/3D modelling
- GD&T
- Medical device design and development
- Product testing and validation
- Design verification and validation
- Risk analysis / FMEA
- Root Cause Analysis
- Design Transfer
- Engineering Change Management
- Supplier Development
- ISO 13485
- ISO 14971
- Technical documentation
Key Performance Indicators (KPIs)
- Product development timelines
- Successful verification and validation
- Product quality and reliability
- Design-change effectiveness
- Manufacturing issue resolution
- Cost optimization
- Documentation accuracy and completeness
- Risk reduction
- Successful design transfer to manufacturing
Pay: Up to ₹40,000.00 per month
Work Location: In person
