Senior Product Development Engineer, Sb
2 days ago
As our team continues to grow, we are looking for a Product Development Engineer to join our team to take on a significant role in this exciting and rapidly developing research. The proposed study aims to develop an innovative therapeutic device for glaucoma.
As a Senior Product Development Engineer, you will be working with, and leading the technical team to develop and work out the quality requirements during the total life cycle of the medical diagnostics devices: from the conception and development phase, through verification and validation, clinical validation, manufacturing and commercial launch, in order to achieve and ensure the final required product quality according to standards such as ISO13485 guidelines for medical devices and ISO14971 for risk management. You shall lead the development activities, including design and assembly of prototype, bench and animal testing to ensure that products comply with quality standards, as per design specifications. This work will be performed under a multidisciplinary project in collaboration with Singapore Biodesign, and Singapore Eye Research Institute. He/She will be expected to interact with vendors, stakeholders (internal and external), such a multidisciplinary team on a daily basis, and therefore strong commu ication skills are required.
**Responsibilities**:
Leads product design verification and validation to satisfy product and customer requirements.
Conducts user/ergonomic studies with clinical professionals during the product development process in pursuit of user-based product design excellence.
Work with vendors and contractors in ensuring quality products are developed
Job requirements
- Bachelor's or Masters degree in Mechanical engineering or in a related field.
- Minimum 5 years working experience in medical device development or product development. Experience with class 3 or high-risk devices will be an advantage
- Experience using CAD software such as SolidWorks or similar.
- Good knowledge in ISO 13485, ISO14155, Good Clinical Practice (GCP), Regulatory Affairs, Medical Device Standards, Intellectual Property Strategy.
- Good understanding and appreciation of quality requirements: ability to derive quality requirements within system structure and process flow from basic principles and establish technical criteria and milestones to track progress of quality during technical development. Experience leading teams to establish product FMEA, DFMEA will be an advantage.
- Ability to communicate effectively and clearly.
- Meticulous, responsible, self-motivated and able to work within tight timelines
- Demonstrated soft-skills to manage and positively contribute to complex teams with people from various backgrounds and discipline skills.
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