Sr Test Engineer
18000 Devonshire Street Sherwood Forest, CA 91325 US
HM's Top Needs:
- Experience with design verification/validation for embedded systems
- Experience with mobile application/Bluetooth low energy testing
- Experience with writing verification plans, test protocols and verification reports as well as defect/change management
Education Required: BS in Systems Engineering, Biomedical Engineering, Computer Engineering, or Computer Science
Years’ Experience Required: minimum 2 years
A Design Quality Assurance Engineer in Verification demonstrates leadership in support of medical device components being developed as a part of a R&D Team in specific areas related to the System Level Verification. The person would act as a focal point for all questions related to Testing activities at system level and collaboratively works with teams to develop and release products.
A successful candidate would work towards meeting objectives established by the Design Quality Assurance Team and the common goals of the entire business unit with a focus on design quality assurance and accountability by:
- Working collaboratively with the R&D and Quality teams across a global team
- Taking a leadership role as a design quality verification representative of the team and ensure projects are being executed as per Quality System Regulations, and GxPs.
- Conducting and moderating Test Plan Reviews, Test Protocol Reviews, Requirements Reviews, and Design Reviews
- Develops and executes test plans, protocols, and reports
- Develop automated scripts using object-oriented programming languages or scripting languages.
- Reviews and researches technologies and their interaction among system components to establish system performance to be tested
- Working closely with stakeholders to establish and support development and testing strategies for the product and system
- Understands the phases of the Software Development Lifecycle (SDLC)
- Supporting completion of milestones
- Performs other related duties as assigned
To be considered for this position, the following basic qualification must be evident on your resume.
BS in Systems Engineering, Biomedical Engineering, Computer Engineering, or Computer Science
REQUIRED YEARS OF EXPERIENCE:
Minimum 2 years of experience in Verification in a regulated industry
- Experience with System Integration Testing or Simulated Use Testing with BLE solutions and mobile applications.
- Experience with Integrated System comprised of Embedded Software, Application Software, Electro Mechanical Control Systems
- Experience with System and Software Configuration Management
- Experience with requirements reviews and management through tools such as DOORs and/or PTC Integrity/Windchill
- Experience with defect tracking and change management
DESIRED/PREFERRED QUALIFICATIONS (optional)
- MS in Software Engineering, Biomedical Engineering, Computer Engineering, or Computer Science
- Experience in Medical Device/FDA Regulated Industry and compliance with IEC-60601,62304, 14971, 62366
- Experience with Control Systems, Micro Fluidics
- Experience with ACE/iAGC/iCGM
PHYSICAL JOB REQUIREMENTS:
Physical capabilities to perform the job
- The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.