DBSI Services · 4 months ago
System Engineer- Medical Device
Orlando, Florida, FL 32808
Full-time
Onsite
Mid, Senior Level
$50/hr - $60/hr
5+ years expDBSI Services is a rapidly growing staffing agency known for building meaningful relationships in various industries. They are seeking a System Engineer with expertise in medical device development, focusing on risk management, product safety standards, and systems design to contribute to the Philips Clinical Applications and Devices Organization.
ConsultingRecruitingStaffing Agency
Responsibilities
Overall technical leadership and responsibility for realization of a new product release and sustaining activity
Translation of user requirements, requirements management, top-level design, feasibility of potential solutions, decomposition of derived requirements
Systems design/architecture and Integration oversight
Support for NPI efforts that create value for Clinical Applications and Devices Organization through innovation and design, while delivering high quality engineering solutions
Technical liaison to the program
Defect/Risk management and Design Reviews
Qualification
Required
BS degree in engineering
Minimum five years engineering / R&D experience in a rigorous quality-focused environment
Minimum three years' experience in a Systems Engineering role, or a role having overall systems responsibility involving electrical (analog and digital), mechanical, firmware and software development disciplines
In depth knowledge performing risk management per ISO 14971
In depth knowledge in developing and testing products to IEC60601-1 Safety standard
In depth knowledge in developing and testing products to IEC62336 EMC standard
Experience leading medical, or other regulated industry, product development
Experience in leading groups to solutions for complex problems
Experience with deriving and simulating human interactions with devices and device use conditions
Experience with electronic requirement data management SW – preferably DOORS
Excellent requirements and specification writing skills
Demonstrated deep understanding of US and international regulatory requirements for a heavily regulated product
Ability to build and maintain effective cross-functional and cross-organizational relationships
Excellent oral, written and presentation skills
Preferred
Understanding of US and international regulatory requirements for medical devices strongly preferred
Experience developing reliability plans
Knowledge of product development processes and best practices
Knowledge of verification and validation testing processes
Electrical or Software development experience is a plus
Master's degree preferred
Company
DBSI Services
DBSI Services is an engineering and technical staffing company with 25 years of expertise in recruiting the best talent.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase