Verification & Validation Engineer

Position Overview

  • Reports to Manager, Quality Assurance
  • Full Time position
  • Competitive salary, stock option package and strong benefits

Summary
The Verification & Validation Engineer will be responsible for the coordination and overall management of product verification and validation activities in the company. This position requires technical expertise in medical device and information system design and development as well as knowledge of quality and regulatory requirements.

Key Tasks

  • Review product, user and technical system requirements for completeness, feasibility and testability of the product and/or system
  • Design and develop repeatable test methods and automated scripts for system verification, taking into account both requirements-based and clinical and business use case-based approaches
  • Propose and implement automated testing methods and procedures for manufacturing processes, verification and validation testing in a DevOps environment
  • Define and implement system integration and test protocols (mechanical, electrical & embedded, mobile and web services software) including design and development of any necessary test fixtures
  • Support Software Release processes and documentation, including execution of software verification protocols as part of each release, developing bug-tracking reports and documentation
  • Continually “stress test” and use the device(s) to identify design and/or manufacturing issues prior to product release
  • Troubleshoot and provide technical assessments of issues encountered internally or by customers in existing products covering multiple domains (e.g. analog, digital and/or software)
  • Contribute to device specification development, error budgeting, reliability analysis, design for manufacturability, and design for cost programs

Job Requirements

  • Bachelor’s degree and 3+ years’ experience, or Master’s degree and 1+ year experience, or PhD in Biomedical, Electrical, Computer, Systems, or Mechanical Engineering is required
  • Experience with product development life cycle in regulated medical device environment
  • Expertise or working knowledge of medical device software quality assurance across range of platforms (Mobile, Embedded, PC and Web)
  • Experience with medical devices performing real-time data acquisition. Experience with EEG systems is strongly preferred
  • Knowledge of and experience with medical device standards such as IEC 60601, IEC 62304, ISO 13485 and ISO 14971

Skills and Abilities        

  • Ability to troubleshoot device problems to the circuit board level using schematics, oscilloscopes, multi-meter, and other standard laboratory test and measurement equipment
  • Beneficial hardware expertise includes: Wireless (RF) communication standards, analog and digital circuit design and Bio-electrical interfaces
  • Familiarity with Linux and Android development tools and environments, JUnit test development, scripting (Bash/Python) and/or coding experience a strong positive
  • Knowledge of SolidWorks, LabVIEW and Matlab a plus
  • Goal driven, confident self-starter with a willingness to continually embrace professional development and a passion to excel
  • Flexibility, willingness to learn, and a demonstrated ability to come up to speed quickly on new technologies and technical issues
  • Ability to operate effectively in a team oriented culture
  • Comfortable working in a fast paced environment
 
 

Qualified applicants are encouraged to send their resume and a cover letter including availability to recruiting@brainscope.com. 


 

The Office of Federal Contract Compliance Programs (OFCCP) has released a Voluntary Self-Identification Form CC-305. All federal contractors are required to use this form in inviting all applicants and employees to provide information regarding their disability status. Completing this form is voluntary and any answer you give will be kept private and will not be used against you in any way. If you choose to complete the form, please attach it with your job application. The form can be found at http://www.dol.gov/ofccp/regs/compliance/sec503/Voluntary_Self-Identification_of_Disability_CC-305_SD_Edit1.24.14.pdf