US, US, CA - San Diego
Minimum Level of Education Required: Bachelors Degree
Percentage of Travel: Up to 10%
Location: CA - San Diego
As our Validation Engineer, you would ensure the quality of the medical device software and hardware meets the design requirements and that they are testable. You would also 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, including DHF and 510(k).
- Follow internal Standard Operating Procedures, including documentation of testing procedures.
- Using problem tracking software, report issues discovered during testing.
- Communicate with Hardware and Software Development, Marketing, 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.
- Train individuals involved in verification and validation activities as needed.
- 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
- 5 or more years relevant work experience
- Knowledge of testing medical products
- Knowledge of FDA/cGMPs 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
Prior experience as quality, regulatory, or design engineer
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.
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally invasive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes.The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.