| Job Description | ABOUT NUVASIVE®
NuVasive is an innovative medical device company focused on developing minimally disruptive surgical products and procedurally integrated solutions for the spine. The Company is the 3rd largest player in the $8.2 billion global spine market. With a focus on Speed of Innovation®, Absolute Responsiveness®, and Superior Clinical Outcomes, we are revolutionizing how spine procedures are performed on patients around the world.
If you work hard to deliver outstanding results and are passionate about making an impact in people’s lives, join our team of A Players and help change spine surgery. We are looking for a highly talented and innovative Senior Manufacturing Engineer to join the Supplier Quality Engineering team at our location in San Diego, California.
SUMMARY
Responsible for assisting in the development, implementation and execution of a Design for Manufacture (DFM) / Design for Assembly (DFA) / Design for Inspection (DFI) program. Responsibilities will also include participation in design transfer to production as it relates to development of manufacturing processes, test/inspection methods, fixturing, gauging and applying inspection and process control techniques. Performs duties in compliance with applicable regulations and standards including FDA Quality System Regulation 21 CFR 820, ISO 13485, and the European Medical Device Directive.
ESSENTIAL JOB FUNCTIONS
· Review designs/prints in both the development and production phases to assure effective use of DFM/DFA/DFI. Reviews will require interaction with interdepartmental personnel such as Development/Design Engineering, Quality Engineering, QC/metrology, Programmers and machinists to create designs and drawings that can be manufactured efficiently with a high confidence of product meeting specifications.
· Advanced knowledge of metal manufacturing processes, especially CNC milling and turning of Titanium, Stainless Steels and PEEK. Other process knowledge including welding, anodization, blasting, laser marking, passivation and assembly is highly desirable.
· Have the ability to read and interpret complex mechanical drawings including advanced
· Geometric Dimensioning and Tolerancing (GD&T) applications.
· Support transfer of design to production for product launch and manufacturing transfers to reduce overall product costs and mitigation of business risks.
· Determine appropriate manufacturing methods and strategies to reduce costs and meet critical to quality requirements.
· Identify validation strategies (e.g. IOPQ, GR&R) for processes and/or equipment. Create validation protocols and reports. Manage execution of strategy.
· Support implementation of manufacturing changes that require qualification and/or validation of new equipment or processes.
· Interface with suppliers on technical issues causing inefficiencies, waste or potential supply chain interruptions.
· Understand and use the Change Control Process.
· Lead CAPA process for non-conforming material reports, out of tolerance reports and product complaints that result from manufacturing issues.
· Other functions include:
· Review technical publications, articles, and abstracts to develop applicable skills and to stay abreast of quality, regulatory, compliance, and technical developments in the industry.
· Attend such conferences, seminars, professional meetings, and other public forums as are relevant to the interests of NuVasive.
· Support other work of the Manufacturing, Supply Chain, Development, QE and QA Departments, as required
· Continue to enhance engineering skills and knowledge of spine market through training and education.
BASIC QUALIFICATIONS:
· 2 year college degree
· Minimum of 6 years experience
PREFERRED QUALIFICATIONS:
Education and/or Experience: A bachelor degree in an engineering discipline (e.g. BSME, BSIE, or BSBME) and a minimum of six years of experience in a manufacturing environment is preferred. Additional experience in lieu of degree may be considered. Experience in a medical device environment (QSR, ISO 13485, and the MDD) is desirable.
Computer Skills: Proficient and accurate with Word, Excel, Outlook, IE, Adobe, Acrobat, and Visio. CAD proficiency (Pro Engineer) preferred.
Language Skills: Ability to read, analyze, and interpret mechanical drawings general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedures. Ability to effectively present information and respond to questions from managers, clients, customers, and the general public.
Mathematical Skills: Ability to apply concepts of basic algebra and geometry, as well as trigonometry, geometric tolerances, and tolerance analysis is required. Knowledge of statistics is desired to support the calculation of process capabilities, Gauge R&R’s, confidence/reliability assessment, etc.
Reasoning Ability: Ability to solve, and interpret problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstracts and/or concrete variables.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, employee is regularly required to sit, use hands to finger, handle or feel and reach with hands or arms. The employee is frequently required to talk or hear. The employee is occasionally required to stand, walk, climb, balance, stoop, kneel, crouch, or crawl; taste or smell.
The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision and the ability to adjust focus.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, employee is occasionally exposed to wet and/or humid conditions, moving mechanical parts, fumes or airborne particles, toxic or caustic chemicals, risk of electrical shocks, explosives, risk of radiation, and vibration.
The noise level in the work environment is usually quiet.
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| | Company | | NuVasive, Inc. | Job Code | | State or Province | | California | | |
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