Description:

  • Perform tests of customer products per submitted Safety Test Plans and associated standards
  • Assists customers in identifying and solving Safety related issues 
  • Write and Review Safety Product Test Plans. 
  • Compile test results and complete Safety Test Reports for submittal to Modality Safety Leader. 
  • Maintain training and competency level required to run equipment and perform testing per the appropriate standards and procedures. 
  • Oversee Safety Laboratory test equipment
  • Assure all equipment is operational and calibrations are current.
  • Maintain operation of all automated equipment and test control software.
  • Define new equipment needs per changes and additions to the Safety test standards. 
  • Stay current on relevant standards and assess laboratory impacts of changes and additions, simplify where possible. 
  • Mentor and Assist with training of Modality Safety Engineers and Technicians to assure competency level of individuals performing Safety tests are appropriate per the relevant standards and procedures. 
  • Perform Safety testing of customer products per submitted Test Plans and applicable standards

Qualifications:

  • BS Electrical engineering, Biomedical Engineering, Physics, Chemistry or closely related discipline & and 4 years of product design and development experience 
  • Knowledge of Safety regulation: IEC 60601-1, Collateral and Particular 
  • Awareness of Local and International Regulatory Agencies 
  • Knowledge of a New Product Introduction process 
  • Knowledge of Quality Management Systems including IEC/ISO 17025 
  • Ability to manage multiple activities effectively
  • Ability to communicate effectively with engineers from different disciplines and varying levels of experience. 
  • Clear thinker, action oriented, high energy, self-starter. 
  • Effective team player with motivating skills. 
  • Strong working knowledge of English language (oral and written)

Preferred Qualifications:

  • Previous experience in an ISO/IEC 17025 accredited lab 
  • 5 years’ experience in the regulated medical device industry 
  • Knowledge of process improvement tools (six sigma, lean, ISO, TQM) 
  • Strong organizational skills with high attention to detail 
  • Adaptable/Flexible: Being open to change in response to new information, different or unexpected circumstances, and/or to work in ambiguous situations 
  • Excellent team-player skills w/global mindset 
  • Excellent interpersonal, organizational, communication and influencing skills 
  • Working knowledge of GEHC products 
  • Strong people networking skills.