Manager, Quality Engineering

Engineering          ·          US, US, CA – Aliso Viejo             ·       Full time

Manufacturing Engineer

• US, US, CA – Aliso Viejo
• Minimum Level of Education Required: Bachelors Degree
• Percentage of Travel: Up to 10%
• Location: Aliso Viejo, CA
• Ref#: 106288

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Job Summary and Primary Responsibilities

Develops, validates, implements, and maintains methods and processes in the manufacturing of components, sub-assemblies, and final assemblies of orthopedic medical devices. Supports new initiatives and productivity targets for given manufacturing processes. Responsibilities will also include participation in design reviews and brainstorming, design transfer to production as it relates to the development of manufacturing processes, equipment and process validations, process definition for machine operation and maintenance requirements, test/inspection methods, fixturing, gauging and applying inspection and process control techniques. 

• Solve problems accross the organization using strong interpersonal skills to build relationships 
• Create process related drawings, fixtures, routers, BOM’s, and any additional material required for manufacturing of electromechanical medical devices
• Utilize ERP/MRP system to define and control manufacturing processes
• Lead investigations and resolutions of production issues on the manufacturing floor
• Create SOP’s and other support documentation
• Participate and investigate nonconformance issues as well as corrective and preventative actions
• Conduct manufacturing related design reviews and train in-house personnel
• Mange installation of new equipment including qualification activities (IQ/OQ/PQ)
• Work with Regulatory Affairs to monitor label requirements across all applicable global regulations and interface with the development engineering teams to ensure compliant execution.
• Define content and support design and placement of all safety and regulatory labels for global markets.

Required Skills / Capabilities

• Ability to effectively communicate information, both formally and informally, such as data, methods, findings, and remediation recommendations at all levels within the organization and with key contacts
• Able to effectively influence others, develop consensus, and create support throughout the organization
• Support design for manufacturability analysis with CNC Programmers and Quality Engineers, and provide input to Development Engineers
• Familiar with implementing, maintaining, analyzing data to react to various production performance metrics and KPIs
• Comfortable with hands-on process development and troubleshooting of electromechanical devices
• Proven ability and fluency in Print Reading and GD&T, Statistical Process Control, Lean Manufacturing, Six Sigma, Siemens NX or Solidworks and Gage/fixture design

Education and Experience

• Typically requires a Bachelor’s degree and three years previous professional experience
• Bachelor’s degree in an engineering discipline (mechanical, electromechanical, manufacturing) preferred
• Experience in 21 CFR 820 and/or ISO 13485 regulated environment

Salary Range: $75,750 – $126,250

For roles that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).

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, age, 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’s EEO policy is available here.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. The Company’s less-invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. The Company’s comprehensive procedural portfolio includes surgical access instruments, spinal implants, fixation systems, biologics, software for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative neuromonitoring technology and service offerings. With more than $1 billion in net sales, NuVasive has approximately 2,700 employees and operates in more than 50 countries serving surgeons, hospitals, and patients. For more information, please visit www.nuvasive.com.

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