System Engineer
SAPSOL Technologies Inc. : Systems and Process Solutions for your Enterprise
contract
Posted on:
Location Type: Hybrid
Location: Orlando • Florida • United States
Visit company websiteExplore more
About the role
- 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
Requirements
- BS degree in engineering
- 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
- 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
- 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
- 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
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
systems designrequirements managementrisk managementverification testingvalidation testingelectrical developmentsoftware developmentDOORSproduct development processesreliability plans
Soft Skills
technical leadershipproblem solvingcross-functional relationshipscommunication skillspresentation skillsspecification writingcollaborationinnovationdesign oversightdefect management
Certifications
BS degree in engineeringMaster’s degree