Scope:
The staff system engineer role provides an opportunity to work with a highly cross-functional group of scientists and engineers to contribute towards next generation products in the field of ophthalmic imaging. The successful candidate will provide technical leadership and actively work with our team of scientists and engineers for projects involving development of next generation ophthalmic imaging devices. The nature of projects may range from new product development, sustaining and improving existing products. Strong grasp on the fundamentals of optical imaging system design, pilot production experience, team-player with effective communication skills, open-mindedness to new ideas and methodical problem solving skills are some of the key attributes that are expected from the position.
Responsibilities include:
- Provide system technical leadership in new product development and work with a highly cross-functional team through various stages of product development.
- Perform in-depth trade-off analysis of technology, systems architecture and design alternatives for new products/platforms.
- Early identification of technical risks or feasibility for new technologies or products and developing a plan for addressing the issues.
- Ownership in following areas: systems architecture and requirements, risk management, product verification & validation and design transfer to manufacturing.
- Conduct FMEA (Failure Mode and Effects Analysis), and other reliability-related tests as needed.
- Strong understanding of integrated optical imaging systems involving integration of light sources, optics, motion control, basic image processing and related sub-systems and technologies.
- Clear communication with vendors to define technical performance requirements and appropriate tolerances.
- Lead product troubleshooting to improve product quality and customer satisfaction.
- Other duties as assigned.
Requirements:
- PhD in optics, biomedical instrumentation, electrical engineering, physics, bioengineering or related field plus 5-7 years of relevant work experience; or MS in related engineering field plus 7-10 years of relevant work experience.
- Track record of delivering complex medical devices to market as system engineer.
- Strong hands-on experience of developing a new product through various stages of product development process.
- Strong grasp of optics, imaging, and system design fundamentals.
- Familiar with system safety and EMC testing (IEC 60601-1 and IEC 60601-1-2), environmental testing, and reliability-related testing.
- Strong problem solving and analytical skills.
- A self-motivated team player who is adaptable and comfortable working in a dynamic, high-paced environment.
Desired Skills and Experience:
- Experience in developing imaging devices and products that required synchronized data collection and instrument control.
- Familiar with ISO 15004 is a plus.
- Experience in pilot production process for medical device.
- Experience in collaborating with doctors and clinical researchers.
- Mathematical modeling skills using MATLAB or other tools