Systems Engineer

Systems Engineer
Location: Norwood, MA 02062
Duration: 12+ Months

Description:
The Systems Engineer will help will help the team design, develop and commercialize new Point of Care products. The talented and passionate individual will be heavily involved in hands-on integration, analysis, troubleshooting of prototype instrumentation / breadboards. The individual will also be responsible for documenting system and subsystem level components for medical diagnostic instruments. 
 
 Duties & Responsibilities: 
 *Demonstrates proficiency in performing root cause analysis and leading troubleshooting 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, FMEAs, risk / hazard analysis, establish technical requirements 
 
 Knowledge & Skills: 
 *Minimum BS in Engineering (Biomedical or Mechanical) is required + a minimum of 8 years of relevant electromechanical medical device experience 
 *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 
 *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) 
  
 * Surveys and investigates the requirements on the technical solution, made from various aspects (customer, law, standards, technical analysis, etc.).* Processes the requirements by analysis, structuring and documentation in transparent form, incl. corresponding sources and stakeholders.* Manages the requirements and maintains the documentation (requirements management).* May check the requirements under formal aspects regarding completeness and unambiguousness.* May check the content of requirements regarding comprehensibility, consistency, cross references, dependencies and later checkability (acceptance criteria).* May evaluate the requirements based on broad experience regarding their feasibility or contained technical risks.* May support the verification of the requirement fulfillment in the execution phase in cooperation with quality management. 

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