Validation Test Engineer
US, US, CA - San Diego
Minimum Level of Education Required: Bachelors Degree
Percentage of Travel: No travel required
Location: CA - San Diego
As a Validation Test Engineer, you will be a key member of the product development team. Your days will be varied as you tackle new challenges including:
- Ensure the quality of the medical device software and hardware meets the design requirements.
- Ensure design requirements are testable.
- Develop, implement and maintain test plans, protocols, test scripts and traceability matrix for design verification & validation.
- Execute protocols/test scripts and document results.
- Generate and/or update summary reports.
- Participate in process improvements.
- Ensure compliance with FDA device regulatory requirements (21 CFR Part 11), including DHF and 510(k).
- Using problem tracking software, report issues discovered during testing.
- Communicate with Hardware and Software Development, Marketing, Regulatory, Technical Services, and other project team members to ensure schedules and requirements are consistent with project expectations.
- Maintain design verification and validation documentation in accordance with established departmental and corporate procedures.
- Participate in review and update of SOPs in the spirit of continuous improvement.
- Possess excellent verbal and written communication skills.
- B.S. Degree in Computer Science, Engineering or related technical discipline
- 4 or more years of relevant work experience.
- Knowledge of testing medical products.
- Knowledge of FDA/cGMPs (21 CFR Part 11) and global regulatory for Medical Devices.
- Good understanding of testing methodology and software development life cycle.
- Adequate discipline and professionalism to work diligently within published FDA device regulatory guidelines and rigorously follow internal Standard Operating Procedures, including documentation of the testing procedures.
- Ability to handle multiple tasks while ensuring timely and accurate completion.
- Proficient in developing test plans, protocols/test scripts, result reports.
- Must be skilled with standard Office applications
- Prefer experience in an Agile driven, Windows application development environment
- Desired experience in electro-mechanical testing using oscilloscopes, meters and gauges.
- Experience with testing for medical device hardware/software.
- Experience with oscilloscope, DVM and other electronic measurement devices.
- Experience working in a Continuous Integration environment.
- Familiar with Agile/Scrum development methodologies.
- Experience testing embedded medical devices at system level (includes software and peripheral hardware components).
NuVasive is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. The “EEO is the Law” poster options are available here.
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