NuVasive, Inc. Senior Manufacturing Engineer in Aliso Viejo, California

Senior Manufacturing Engineer

US, US, CA - Aliso Viejo

Minimum Level of Education Required:Bachelors Degree

Percentage of Travel:Up to 10%

Location:CA - Aliso Viejo

Ref#:17182

Job Description

Job Summary:

This position will play a key role in product transfer from advanced R&D to production. The purpose of the position is to integrate manufacturability into the development process as well as design and develop any tooling or processes needed to reliably manufacture new designs.

Essential Duties and Responsibilities:

· Participates closely with R&D project teams in design and development of new projects, in anticipation of new product introductions.

· Design jigs/fixtures that ensure materials are produced efficiently and conform to print specification.

· Support the design, manufacture, and coordinate the procurement of dimensional and functional jigs / fixtures for tooling validation

· Support the task of integrating new manufacturing fixtures and equipment in production with emphasis on mistake-proofing

· Coordinate engineering change activities for manufacturing.

· Lead the manufacturing transfer of Class III active implantable spine and orthopedic devices.

· Implements, organizes, and scales up manufacturing processes from pilot line to product launch.

· Review mechanical assembly drawings for complete notes, and attention to DFM

· Develop manufacturing plans, project timelines, requirements, and process flow.

· Conduct manufacturing related design reviews and train in-house personnel.

· Manage installation of new equipment including qualification activities (IQ / OQ / PQ).

· Brainstorm solutions to resolve technical issues encountered during manufacturing.

· Drive process improvements affecting yields, capacity increases, cycle time and cost reduction initiatives.

· Participate in manufacturing risk management activities such as design and process FMEAs

· Interface frequently with internal departments including R&D, Regulatory, Quality, Marketing

· Oversee initial product builds (engineering units, pilot units, process validation units and coordinate a smooth transfer of new products to production.

· Work in accordance with Quality system procedures and actively enforces its objectives

· Process improvement skills including the use of ‘Lean’ tools to drive increased manufacturing productivity, efficiency and safety.

· FDA design controls and clinical good manufacturing processes (cGMP)

· ISO 13485 / CE Mark

Basic Qualifications

· B.S. in Mechanical or Biomedical engineering.

· Minimum of 8 years in medical device manufacturing

· Experience in new product introduction of medical implants

· Excellent analytical, problem solving, technical writing

· Effective cross functional communicator with both internal and external customers and partners

· Up to date with best practices for electronics DFM

Preferred Qualifications

· Comfort zone includes creation of advanced custom tooling tailored to new products

· Functional familiarity with the FDA submission process

· Familiar with methods of provided automated/semi-automated processes to improve consistency of process.

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 at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm .

About NuVasive

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.

©2015 NuVasive®, Inc. Privacy at http://www.nuvasive.com/privacy-policy/ Terms and Conditions at http://www.nuvasive.com/terms-conditions/

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 at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm .

Nuvasive is committed to working with and providing reasonable accommodation to individuals with disabilities. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at careers@nuvasive.com.