Staff System Engineer

This systems engineer role provides an opportunity to work with a highly cross-functional team including scientists/engineers, clinical/regulatory and marketing staff to contribute towards successful ophthalmic medical products. The nature of projects may range from new product development, sustaining and improving existing products. The successful candidate will provide technical leadership in systems engineering related areas including system requirements specification, system architecture and design, and system verification and validation. The systems engineer also assumes the following responsibilities as required: support product sustaining, improve product reliability and quality, and conduct testing to meet medical device standards. 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. Senior or Staff title will depend on the candidate’s experience and qualifications.

Essential Responsibilities

• Participate in new product development and work with a highly cross-functional team through various stages of product development.
• Plan and conduct in-depth reviews, testing and verifications/validation of product features. Conduct design transfer to manufacturing team.
• Perform trade-off analysis of technology, systems architecture, and design alternatives through simulation, test, and measurements.
• Early identification of technical risks and developing a plan for addressing these issues.
• Provide technical leadership in qualifying new parts/modules and confirming system performances to support product sustaining.
• Lead product troubleshooting to improve product quality/reliability.
• Identify and build improvements or enhancements to existing products.
• Other duties as assigned.

• PhD in optics, biomedical instrumentation, electrical engineering, physics, bioengineering or related field plus 3 years of relevant work experience; or MS in related engineering field plus 5 years of relevant work experience.
• Track record of delivering complex medical devices to market as systems engineer and good documentation with the compliance to medical device design control standard, e.g. ISO 13485 and FDA 21 CFR 820.30.
• Hands-on experience of developing a new medical product through various stages of product development process.
• Familiar with system safety and EMC testing (IEC 60601-1 and IEC 60601-1-2), environmental testing, and reliability-related testing etc.
• Strong understanding of integrated optical imaging systems involving opto-mechanics, electronics, basic image processing and related sub-systems and technologies.
• Strong problem solving and trouble shooting skills.
• A self-motivated team player who is adaptable and comfortable working in a dynamic, high-paced environment.
• 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 devices.
• Experience in collaborating with marketing, doctors and clinical researchers.
• Mathematical modeling skills using MATLAB or other tools