JOB TITLE: Sr. Medical Device Test Engineer level 2 & 3
DEPARTMENT NAME: System Test Engineering
No. of positions: 2
LOCATION: San Diego and Rancho Cordova, CA
Are you ready to improve healthcare? Are you ready to be a part of the company which is revolutionizing the medical device industry, finding innovative ways and cutting edge technologies to increase patient safety reduce risks and improve how healthcare is delivered. Our system test engineering team tackles this very challenge. As a member of the team, you will work with Engineers to ensure that the medical device product meets all its requirements and its intended use. You will work through all phases of product development through rollout and into production release and test the system as we are gradually build the system and be part of the entire PDLC of a medical device.
DUTIES AND RESPONSIBILITIES:
- Perform and/or Participate in design reviews, SRS reviews, TSR reviews and systems requirement review to develop thorough test designs and test cases for complete test coverage
- Create and maintain the test cases for SW, HW, mechanical and electrical components of the system as well as the fully integrated system
- Actively work on building reusable and robust test case process to gain operational efficiencies in test case development and test case execution under a diverse collection of operational scenarios,
- Analyze requirements and confirm that requirements are actionable, measurable and testable
- Provide effort estimates for test documentation, test preparation and test reporting using estimation models
- Develop Master Verification plan and System Verification plan for multiple projects
- Employ established test strategy and tactics on assigned projects and ensure full execution of the strategy
- Create and Execute smoke, functional, regression, system (E2E) and performance tests according to established verification plan in Agile test environment for SW, electrical, mechanical and packaging
- Review junior staff engineers test designs, test cases and test procedures for accuracy, efficacy and completeness
- Train junior staff engineers on testing practices and help them improve their overall product knowledge
- Report defects and assist developers in reproducing defects and assist in finding the cause to various defects.
- Define project entry, exist and release criteria to ensure quality targets are met.
- Define key progress indicators from testing perspective and provide regular test summary dashboard to all key stakeholders
- Create multi-dimensional traceability matrix report between test cases, requirements and defects
- Create automated test cases, custom functions and procedure to support automation framework
MINIMUM QUALIFICATIONS, KNOWLEDGE, SKILLS AND ABILITIES: (This will include education, and knowledge and experience)
- Requires a Bachelor's degree in BME, EE, Physics, Computer Science, Computer Engineering, Mathematics, or Systems Engineering with 5+ years of experience electrical, mechanical, software, or signal processing aspects of system design; 2+ years’ experience in systems engineering preferred in the medical device industry.
- Experience with scientific computing applications.
- Understanding of theories and principles of domain (preferably in a medical setting).Previous Experience in Medical Device Industry
- Understanding of QSR, ISO9001, 13485 and other international standards
DESIRABLE QUALIFICATIONS: (Additional qualifications – “nice to have” but not a deal breaker ex, certifications etc)
- Experience leading test team
- Medical instrument development and industry experience
- Ultrasound Experience
- Signal/Image processing experience
- Knowledge of embedded applications
- DICOM experience
- Familiar with a Requirements Management tool, ex- Caliber RM
- Analog/Digital Electronics
- Demonstrate experience in leading test team
- Solid Experience in waterfall or iterative development and testing methodology
- Good experience in automated testing tools to support and assist the company testing efforts
- Understanding of test automation and performance testing methodologies
- Knowledge of relevant automation technology, tools and software’s preferably Mercury Suites of products Quick Test Professional, Load Runner, Test Director) is a plus
- Excellent analytical skills.
- Ability to organize and prioritize workflow in order to meet established time frames and schedules.
- Assimilate techniques from scientific literature.
- Develop intellectual property and support patenting process.
- Familiarity with cardiology catheterization procedures, tools, and terminology.
- Remain current in discipline and domain.
- Occasional travel will be required to company sites. Approximately 20%
- Ability to lift up to 25 lbs
- Ability to see the letters and numbers on a personal computer screen and on memos, reports and other documents (near vision)
- Prolonged sitting or standing required, up to 8+ hrs/day