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.