Sr. Validation Engineer, Manufacturing
US, US, CA - San Diego
Minimum Level of Education Required: Bachelors Degree
Percentage of Travel: Up to 25%
Location: CA - San Diego
The Senior Validation Engineer will lead efforts to validate all equipment used by the Global Prototyping and Manufacturing Engineering team in San Diego. They will also participate in New Product Development (NPD) process by providing support and guidance to NPD teams for process validations required during the NPD process. These validations may be conducted at NuVasive’s internal manufacturing facility in Ohio or at any of our Contract Manufacturer facilities. Responsibilities will include authoring and approving validation protocols and reports. The role will also include management of the Validation Master Plan for the Global Prototyping and Manufacturing Engineering Team.
Duties to be performed in compliance with applicable regulations and standards including FDA Quality System Regulation 21 CFR Part 820, ISO 13485, and the European Medical Device Directive.
- Author and execute protocols and reports for IQs, OQs, PQs and PPQs. Validations will include new or changed processes, systems or equipment.
- Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of manufacturing problems.
- Lead periodic review of equipment and critical utilities.
- Lead cleaning validation and annual monitoring projects.
- Conduct audits of validation or performance qualification processes to ensure compliance with internal and regulatory requirements.
- Conduct Quality planning to establish and implement timely validation plans, risk analysis, control plans, and inspection plans for in-process and final inspection.
- Manage CAPA or Process improvement projects driving root cause investigation and corrective action implementation.
- Train, guide, influence and mentor other Engineers in Validations or Root Cause Analyses
- Support of process development, process monitoring and production transfer activities.
- Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485, 21 CFR 820, and the European Medical Device Directive.
- 8+ years of related experience
- Bachelor’s degree
- Familiarity with processes in a CNC Manufacturing environment
- Ability to read and interpret mechanical drawings, including GD&T, is strongly preferred
- DOE and Applied statistical knowledge and experience is preferred
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.