Manufacturing Engineer

Established Search is partnering with a growing start-up in the Interventional Cardiology space to recruit a Manufacturing Engineer to support and scale the production of its medical device portfolio. This is a full time, on-site role.Key ResponsibilitiesProduction, Equipment, and Asset Management (QMS-compliant):Perform hands-on calibration, maintenance, and troubleshooting of production and warehouse equipmentManage third-party service providers and vendorsAssess, plan, and implement equipment upgrades or the introduction of new equipmentEngineering Change & Documentation Support:Support engineering change management activitiesPlan, execute, and implement design and process changesMaintain technical documentation in accordance with QMS requirementsPrepare training materials and deliver training to production personnelQuality Assurance & Regulatory Affairs Support:Support engineering-related activities for NCMRs and CAPAsParticipate in and support internal and external auditsProcess & Design Optimization:Identify opportunities for production and process improvementsSupport the planning and execution of process optimization initiativesRequired Qualifications & SkillsBachelor's degree (or higher) in Biomedical, Mechanical, or Electrical EngineeringMinimum of one year of experience in a highly regulated environment with a strict QMSStrong technical expertise with proven troubleshooting capabilitiesHands-on experience in equipment maintenance and calibrationFluent in English and Dutch, both written and spokenProficient in Microsoft Office applicationsSelf-motivated, open-minded, eager to learn, and a collaborative team playerTo be considered, please apply directly or email adam.love@established-search.com with your CV and a short note.Please note; I anticipate a high volume of applicants and I'm simply unable to respond to all. If you do not meet the above criteria and haven't heard from me within 14 days of applying, please assume your application has been unsuccessful.