Sr. Engineer, Manufacturing

US, US, OH - West Carrollton

Minimum Level of Education Required: Bachelors Degree

Percentage of Travel: Up to 10%

Location: OH - West Carrollton

Ref#: 100161

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Job Description

As a Senior Manufacturing Engineer at NuVasive Manufacturing focused on project leadership, each day will offer new challenges as you tackle a variety of responsibilities to support the development, production, and commercial launch of medical devices.  As a seasoned ME, you’ll take ownership of projects for new and existing products manufactured in our plant, specifically by determining manufacturing processes required to accurately and efficiently make spinal implants, from raw material to final cleaning, packaging, and shipment.  You’ll work with and lead cross-functional teams to execute and document the manufacturing launch of new/legacy products.

Essential Responsibilities:

·        Collaborate with Quality Engineering to determine critical manufacturing process and control characteristics.

·        Develop and complete manufacturing documentation (pFMEA, control plan, process flow, work instructions, and inspection plans).

·        Perform research, design, and development of manufacturing processes including production flow, assembly methods, and production equipment.

·        Execute the Engineering Change Process for process updates and improvements.

·        Perform product/process analysis and troubleshooting for cost reduction, quality improvement, and improved efficiency.

·        Design, develop, test, source, and cost-justify various tools, machinery, and equipment for recommended manufacturing methods.

·        Coordinate and manage the estimating/quoting process.

·        Lead design for manufacturability analysis with CNC Programmers and Quality Engineers, and provide input to Development (Design) Engineers.

·        Support process validation by working with validation engineers to clarify methods, inputs, and outputs of processes or equipment.

·        Implement, maintain, analyze and react to various production data logs.

·        Participate in NCMR Process in containment, root cause analysis, and implementation of permanent corrective actions.

·        Understand basic anatomy and physiology of the spine and procedures for which products will be designed and developed.

·        Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485.


Basic Qualifications
  • Bachelor’s degree in Engineering
  • 5+ years’ experience in medical device manufacturing
  • Orthopedic and interbody implant experience required
  • Strong proficiency with ProE or other CAD software
  • Effective communication skills with strong confidence to present before groups of customers, vendors, peers, and leadership.
  • Proficiency with Microsoft Office with a strong ability to write procedures and reports.

Preferred Qualifications
  • Lean Six Sigma practitioner
  • Ability and fluency in Print Reading and GD&T, Statistical Process Control, Manufacturing,
  • Experience in 21 CFR 820 and/or ISO 13485 regulated environment
  • Experience in a CNC manufacturing environment 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.

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.
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