Systems Engineer Job in San Diego, California US
Position: Systems Engineering / Architect
Location: Rancho Bernardo, California
Moog Medical Devices Group (MMDG) is a designer, manufacturer and distributor of medical devices including diagnostic and therapeutic systems, optoelectronic devices, ultrasonic sensors and surgical hand pieces. The founding idea of improving and saving lives is embodied in our ever-expanding vision of Technology Transforming Life. At MMDG, we make it happen every day with our proprietary products and Applied Technology partners. With an eye on the future, the employees of MMDG continue the founding mission of quality, service, and innovation.
Position Summary:
This is key product development role focused on the development of next generation medical device and PC products within the framework of FDA design controls, ISO13485 and other international standards. Ideal candidates will have at least 5 years of design experience within a medical device environment and experience leading product development projects to develop embedded and application software. This is an exciting growth opportunity for an experienced design engineer with a passion for new product development.
Scope and Responsibilities:
Reporting to the Engineering Manager/Director, this position participates in the system design and definition of embedded medical devices and supporting PC products. The position is required to work in a cross functional team as well as internal and external partners and a global engineering team.
Project Management
*Leads Product Development Projects using prior project management skills Defines project scope, schedule and deliverables
*Manages budget, resources
*Monitor projects and report on progress of the project to all stakeholders
Technical
*Support development of new product platforms and iterations of our IV Pumps
*All stages of the development life cycle beginning with concept development, requirements engineering, architecture, design and development, reviews, verification testing and software maintenance
*Monitor technology trends and standards for emerging technology opportunities
*Works with minimum supervision to analyze significant and complex issues to present effective and characterized solutions
*Utilize understanding of Design Control Procedures to support projects from concept to launch
*Utilize understanding of software development process and lifestyle and ISO62304
*Working knowledge of medical device risk analysis and the ISO14971. Support development of hazard analysis and assurance cases
*Participate in FDA inspections, ISO Certification and customer audits
Education and/or Experience
*Degree in Biomedical Engineering or Electrical Engineering
*Bachelors degree with 5 -9 Years related experience OR
*Masters degree with 3 -7 years related experience (Preferred)
Other Qualifications:
*Technical: RTOS, Windows
*Familiarity with digital circuits using micro-controllers, electro mechanical devices and sensors
*Familiarity with embedded C" compilers, assemblers, in-circuit emulators, timing analyzers, oscilloscopes
*Wireless experience a significant plus
*Prior experience with Software development requirements of medical devices ( FDA QSR )
*Prior experience with disciplined software product development lifecycle
*Prior experience with device hazard analysis and DHF
*Excellent Communication Skills
*Ability to work in a team environment as well as independently
Benefits:
Moog Medical Devices Group offers a wide range of benefits, including, comprehensive medical and dental insurance at competitive rates, life insurance, short and long term disability insurances, 401(k) plan with a company match, generous paid time off policy for work life balance, and the opportunity to work in a team environment.
How to Apply:
If you are interested in joining a progressive and fast paced company, and have what it takes to make a positive impact, complete an application via the Moog on-line Career Center located at: www.moog.com .
Equal Opportunity Employer
