Systems Engineer 2

Hello,
 
We have an excellent opportunity with our client for the position of Systems Engineer 2 at Norwood, MA. Please review the information below and if you are available; please reply back with a copy of your resume and best number to reach you.
 
Title: Systems Engineer 2
Location: Norwood, MA 
Duration: 12+ months (high possibility of extension)
 
Description:
The Sr. Product Engineer will help the team design, develop and commercialize new Point of Care products. The talented and passionate individual will be involved in Integrating, analyzing, testing, and will be responsible for documenting system and subsystem level components for medical diagnostic instruments. 
 
Duties & Responsibilities 
Demonstrates proficiency in performing root cause analysis and initiating and leading troubleshooting activities. This person leads activities related to failure mode and error analysis of a next generation type II medical device. 
Leads the development of test plans and data acquisition in support of ongoing product development as well as informal (dry run) and formal (design V&V) testing of complex electro-mechanical, software-driven medical devices; responsibilities may include managing systems HW& SW integration, software loads and updates, configuration control, and test execution and reporting. 
Works with subsystem teams, domain subject matter experts, and suppliers in the identification, logging, assessment, and resolution of integration and test issues. 
Specify, design, and develop test systems (hardware & software); ensure that all test systems and equipment are appropriately validated and controlled 
Collaborates with a diverse technical team to create, update, and maintain documentation that is or will become part of the product design history file (DHF) for a medical instrument. 
Work closely with all engineering disciplines, including Systems, Electrical, Mechanical, Disposables, and Software Engineering, as well as Project Management and Quality personnel, to verify and validate product designs. 
Applies knowledge of regulations and standards including: FDA design controls, ISO 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971. 
Perform design reviews, FMEA’s, risk / hazard analysis, establish technical requirements 
 
Knowledge & Skills: 
Minimum BS in Engineering (Biomedical, Mechanical or Software ) is required + 5 years of relevant experience 
Electro-mechanical product design experience throughout the design life cycle is required 
Experience with application of fluid dynamics, heat transfer, electronics & programming are required 
Adapts to change quickly and is able to multi-task, managing several activities or projects simultaneously. 
Demonstrates technical confidence to interact with engineers of other disciplines, supports technical discussions, and demonstrates the ability to make technical decisions 
Ability to understand complex system interactions and the effect on analytical performance 
Proficiency with data acquisition, analysis and statistical techniques using Labview, MatLab, Minitab etc. Expert competency with LabVIEW is a plus 
Experience in fluidics and designing small fluidic systems 
Demonstrated understanding of product development considerations for tightly controlled manufacturing processes 
Clear understanding of product and process validation including V&V, TMV, FAI, FAT/SAT IQ/OQ/PQ etc. 
Excellent understanding of medical device product development risk management methodologies 
Knowledge of Design of Experiments (DOE), Design for Six Sigma (DFSS), Design for Manufacturing/Assembly (DFMA) 
Ability to produce quality written work, such as, technical reports, protocol and plans. 
Ability to clearly communicate ideas and knowledge (upward and downward) to other individuals and teams - both in writing and verbally 
Basic understanding of IP considerations 
Experience with ISO requirements and GMP guidelines, FDA regulations, medical device design control, and manufacturing scale up processes
 
Regards
 
Ronny Dsouza
APN Software Services INC
39899 Balentine Drive, Suite 385, Newark, CA 94560
ronny@apninc.com
Phone: 510-870-8707

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