Role : Deputy Manager - Mechanical Design Engineering - NPD + Sustenance Engineering
Location : Bengaluru, India
The Mechanical Design Engineer is responsible for supporting the design & qualification of new and existing products.
Role in a nutshell:
- Support multiple projects that are ranging from new product development to life cycle management/ sustaining engineering.
- Support in design requirements and development of specifications based on user requirements.
- Contributes to development and documentation of mechanical system architectures.
- Contributes in ideations, troubleshooting and problem-solving efforts related to new product development and sustaining projects.
- Hands-on experience in Design History File compilation / Technical file documentation.
- Support internal and external inspections/ regulatory audits.
- Promote continuous improvement in design control activities and use of quality tools with design team.
- Knowledge and understanding of 21 CFR Part 820 Quality System Regulation, ISO 13485 Quality Standard, 21 CFR 4 Regulation of Combination Products, 14971 Risk Management Standard.
- Exposure to complaint investigation, corrective action and preventive action system, statistical methods, quality risk management and Post Market Surveillance.
- Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting devices can be adequately manufactured and verified.
- Creates and develops designs of mechanical assemblies, mechanisms, and component parts for electro-mechanical medical devices meeting set requirements.
- Must be able to participate in design reviews for reviewing the design changes & seek management approval to move forward.
Qualifications and Skills:
- A graduate or a postgraduate in Mechanical or related engineering and 4-6 years related experience. Exposure to medical device lifecycle management preferred.
- Knowledge and experience using CAD systems for mechanical design and analysis (SolidWorks preferred).
- Knowledge of standards such as IEC 60601, ANSI and ASTM preferred.
- Knowledge on Risk assessment, Root cause analysis procedures, DFMEA, PFMEA, ISO, etc is desirable
- Knowledge of DFM & DFA with respect to ease of manufacture and assembly.
- Knowledge of Design and manufacturing Engineering of metal and plastic parts is required.
- Excellent communication skills- Written and oral such as technical documentation, Presentation skills.
