Senior/ Product Engineer
6 days ago
We are looking for solution-minded **Senior/ Product Engineer (Mechanical) **to join our team located in Singapore.
Medulla Pro offers the world’s first real-time needle ultrasound-guided device that is accurate, easy to use, and safe. It drastically eliminates the traumatic incidents for the patients and cut down the procedural time significantly
The simple and practical device explores unique ultrasound deflection methodology for real-time, calibrated, accurate needle entry into the lumbar. It enhances the experience of the patient undergoing the procedure and improves the confidence of clinicians administering it.
Medulla Pro is developing the system in partnership with the National Healthcare Group (one of the major health care clusters in Singapore) and Trendlines Labs.
**Roles & Responsibilities**
- Contribute to the development of the product by optimizing product design, related accessories, and packaging
- Maintain product BOM to latest with revision traceability
- Lead in establishing design specification and development of clinically relevant test methodology that would meet the specifications
- Responsible for the production and assembly of prototypes, tooling and test equipment with suppliers and ensure timely deliverables.
- Liaise and manage subcontractors, planning, implementing, monitoring, and controlling product development processes
- Maintain AutoCAD models, drawings and other required documentation according to ISO 13485 requirements
- Work with external laboratory testing to ensure product meets required medical device standards
- Support in other project and skills related activities
**Skills & Requirements**
- Bachelor’s degree in mechanical/biomedical engineering, or related technical degree
- Experience in design using CAD software (Solidworks, ProE/Creo, Unigraphics) and technical drawings
- Product development experiences in medical products
- Minimum of 2 years experiences in a manufacturing environment (i.e: Product development/ production/manufacturing)
- Knowledge of in IQPQ, validation, validation processes for medical devices is an advantage
- Knowledge of regulatory processes will be an added advantage
- Knowledge in solving and troubleshoot technical problems. Uses creative and innovative approach in problem solving
- Familiar with plastic molding fabrication process, molding construction and process optimization
- Attention to details and is highly analytical
- Comfortable working independently or as a team and proactive
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