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Sr. Manufacturing Engineer - Orthobiologics

Company: SeaSpine
Location: Irvine
Posted on: May 3, 2021

Job Description:

This position is responsible to develop and improve new as well as existing manufacturing methods, fixtures, equipment, and processes utilizing innovative approaches to produce a high-quality product at optimal cost. Projects assigned are typically of high visibility, complex nature, and broad scope that can pose significant risk to product and/or processes if not designed and implemented correctly.Essential Responsibilities:Provide engineering support to manufacturing operation to meet manufacturing objectives and address product related issues arising from the production floor on a routine basisPerform timely technical investigations and provide practical manufacturing solutions utilizing problem solving skills and techniques to identify root causes, corrective and preventative actions, develop and implement mitigation and resolution plans and activitiesDefine and generate all required documentation in support of manufacturing products and processes ensuring compliance with FDA GMPs, applicable regulatory standards, and internal protocols/procedures. These include but are not limited to: IQ/OQ/PQ/PV validation protocols and reports, FMEAs, packaging design and validation, equipment and tooling design, and manufacturing proceduresContinually improve manufacturing methods, systems, and processes to optimize product performance and reduce manufacturing costs. Identify and evaluate opportunities for improvement make specific recommendations for adoption, and drive implementation. Develop plans to evaluate process repeatability and stability through equipment qualification and process validation applying six sigma methodologies as appropriateLead and coordinate activities of cross functional teams which may include personnel from Engineering, Manufacturing, Research & Development, Marketing, QA, and Clinical & Regulatory AffairsSupport new product development or existing product line extensions/modifications (R Design Transfers or Plant Transfers) by ensuring manufacturing processes are designed to facilitate ease of manufacturing and to produce quality, cost effective products with optimized yieldsDesign and/or specify equipment, fixturing or tooling per manufacturing requirements and product specificationsProactively address manufacturing equipment issues, specify corrective and preventative repairs and/or upgrades, and initiate capital equipment requests for new and replacement equipment as neededRequired Qualifications:BS in Engineering6+ years in medical device manufacturing or manufacturing in highly regulated environmentProficient in statistical analysisStrong ability to effectively communicate verbally and through written correspondence with all levels of peers and leadership at SeaSpine and other vendorsStrong proficiency with Microsoft OfficeDemonstrated ability to work creatively, prioritize, and smoothly manage goals and initiatives amidst competing prioritiesCritical thinker with strong attention to detail, and ability to problem-solve and establish solutions in a high-growth and fast-paced environmentStrong project management, time management, and analytical/problem-solving skills as demonstrated through work experiencePreferred Experience:Six Sigma Green Belt / Black Belt or Lean Manufacturing certificationCertified Manufacturing Engineer (CMfgE)Experience in biomaterialsExperience with Computer Aided Drafting programs (Soildworks, ProE, AutoCAD)Knowledge and applicable understanding of Geometric Dimensioning and Tolerancing (GD)Lyophilizer and autoclave equipment expertise, and ISO Class 5 isolator aseptic processing Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

Keywords: SeaSpine, Irvine , Sr. Manufacturing Engineer - Orthobiologics, Other , Irvine, California

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