DUTIES AND RESPONSIBILITIES:
- Serve as functional head of the Engineering (Electrical) team. Lead electrical engineering team in design and development of medical systems on time and on budget.
- Apply electrical and electronics engineering knowledge to the design and development of new products as well as product changes and enhancements.
- Develop appropriate electrical documentation, including project schedules, hardware requirements, detailed designs, test plans and procedures and training instructions.
- Collaborate with the cross-functional teams to establish the product vision and roadmap.
- Work closely with a multidisciplinary team to drive cost optimization, manufacturability, quality and reliability.
- Drive the definition of hardware architecture and selection of technology platform(s).
- Generate written reports that can clearly contribute to the Design History File.
- Effectively communicate project status with management and the team.
- Contribute to the company's intangible asset strategy via trade secrets and patents.
- Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company products.
- Provide engineering support in the resolution of product complaints and/or safety issues.
- Oversee outside vendors and consultants as required.
- Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and regulations.
- Participate in electronics development for the pilot and later stage production of the system.
- Design and oversee the electronics hardware design activities of the whole product.
- Create procedures for implementation and testing of system.
- Maintain the hardware development life-cycle process, including requirements, design, implementation, integration, testing, and release.
- Provide technical support of products introduced into both the domestic and international markets.
QUALIFICATIONS (EDUCATION, EXPERIENCE, SKILLS):
- BS, MS, or PhD in Electrical/Electronics Engineering, Computer Engineering, or related field
- Minimum of 5 years professional experience in electrical / electronic design in healthcare or other highly regulated industries such as automotive.
- Must have gone through at least one new product development cycle.
- Experience with designing electronic to comply with EMI/EMC and safety regulatory certifications
- Experience with DFx methodologies.
- Experience with PCB design software (eg. Altium Designer) is preferred, though not necessary.
- Knowledge of Medical regulatory standard such as IEC 61508/IEC 60601 is a plus.
- Candidates who require work pass need not apply.
