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|Job Category :||Engineering|
|Position Name:||Sr. Engineer, Production|
|Location :||Wayne, NJ|
|Job Description :||Sr. Engineer, ProductionWayne, NJ, US Together we can make a Difference!At Getinge we are dedicated and passionate about helping our customers save lives and ensure excellent care. We provide innovations for operating rooms, intensive-care units, sterilization departments and for life science companies and institutions. Our portfolio combines well-known product brands such as Maquet, Pulsion, Atrium, Lancer and Datascope – just to name a few.A career at Getinge will provide career opportunities that both inspire and challenge. Here, you can make a difference every day.ResponsibilitiesThe primary responsibilities of the Senior Manufacturing Engineer position are:Lead projects in the areas of process and product improvements, including cost reduction projectsInvestigation and response to production issues or to customer complaintsMentor lower level engineersEnsure compliance to regulations of FDA, and other regulatory bodiesAssist in the transfer of new products from NPD (New Product Development) to Manufacturing.Develop and maintain production documentation such as procedures, routers, BOMs.Job Responsibilities and Essential DutiesResponsible for the development/refinement of production processes and equipment; development and execution of process validations (Installation, Operational, & Process Qualifications) with sound engineering practices, and within company policy and regulations of FDA, and other regulatory bodies. The Senior Engineer utilizes a wide range of engineering principles, theories and concepts in the manufacturing/mechanical engineering discipline, plus a working knowledge of related disciplines to solve a wide range of difficult problems with imaginative and practical approaches.Provides training and guidance to lower level Manufacturing Engineering personnel. Guidance may be technical or project related as Project Leader or Lead Engineer of small to medium projectsSupport efforts for complaint investigation compliance with the Food and Drug Administration (FDA), European Union Medical Device Directive (MDD), European Union Medical Device Reporting (EUMDR), Alternate Summary Report (ASR), and applicable regulations and regulatory governing standards.Ensure timely and accurate investigations of returned products to support effective complaint closures as required by Complaint Engineering group.Supports the FDAMinimum RequirementsBachelor of Science degree in Mechanical, Manufacturing or Biomedical Engineering with 7 years of experience in manufacturing and engineering.Required Knowledge, Skills and AbilitiesStrong technical and analytical ability.Effective verbal and written communication skills and interpersonal skills. Team player.Experience with project management, process development & process validations.Demonstrated ingenuity and creativity.Proficiency with Microsoft Office applications.Working knowledge of statistical analysis., and DOE (Desogn of Experiments).General knowledge of Lean Manufacturing and Six Sigma principles.General understanding of GMPs (Good Manufacturing Practices) and FDA regulations and other 3rd party audits as required by Complaint Engineering group.Excellent Opportunity to join an industry leader! Excellent Benefits!… Dental, Health, Vision, Life and 401(k) and more! Interested candidates please send your resume.Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.We look forward to receiving your application. If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application. We hope you will join us on our journey to become the world’s most desired medtech company.INDMMJob Type: Full-timeBenefits:401(k)Dental insuranceHealth insuranceLife insurancePaid time offVision insuranceSchedule:Monday to FridayWork Location: Multiple Locations|
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