[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"project-requirement-engineer":3,"similar-requirement-engineer":37},{"id":4,"slug":5,"title":6,"skills":7,"budget":21,"duration":22,"location":23,"onsitePercent":21,"contractType":24,"foundAt":25,"category":26,"description":30,"rawText":31,"webTitle":32,"webText":33,"language":34,"projectId":35,"sourceUrl":36},6245,"requirement-engineer","Requirement engineer",[8,9,10,11,12,13,14,15,16,17,18,19,20],"Requirements Engineering","ALM","CPRE\u002FIREB","CCBA\u002FIIBA","INCOSE","System Engineering","Software Engineering","Medical Engineering","IVD","V-model","EARS","German","English",null,"12+ months","Rotkreuz","temp_work","2026-05-27T10:36:37+00:00",{"id":27,"slug":28,"label":29},14,"medical_tech","Medizintechnik","Requirements Engineering für diagnostische Instrumente bei Roche Diagnostics. Technische Anforderungsdefinition für Hardware\u002FSoftware in regulierter Umgebung. Zusammenarbeit in interdisziplinären Entwicklungsteams.","Requirement engineer\n\ntemporary\nRequirement engineer\nRequirement engineer Hardware \u002F Software: Requirements Engineering \u002F ALM \u002F CPRE\u002FIREB, CCBA\u002FIIBA, or INCOSE \u002F System Engineering \u002F Software Engineering \u002F Medical Engineering \u002F IVD \u002F Diagnostic Instruments\u002F German\u002F English\nBackground:\nThe Sub-Chapter Instrument Design Verification is part of R&D Near Patient Care, which is accountable for research and development activities on all systems of the Near Patient Care portfolio from Roche Diagnostics.\nWe are looking for someone with a technical background, ideally in system engineering, software engineering or medical engineering who brings experience in software and hardware requirement engineering – and eventually testing – for diagnostic instruments.\nThe Perfect Candidate:\nThe perfect candidate brings over 5 years of experience driving the full product development lifecycle, with a sharp focus on requirements engineering within highly regulated environments, ideally in In Vitro Diagnostics (IVD) or medical device development. They possess a deep understanding of the V-model and extensive hands-on expertise in requirement analysis, structuring, and breakdown using advanced ALM tools.\nTasks & Responsibilities:\n* Definition of technical requirements for diagnostic instruments based on business and customer inputs, risk ratings and context according to internal Roche guidelines\n* Knowledge in definition of requirements using EARS (Easy Approach to Requirements Syntax)\n* Contribution to the development of requirement engineering concepts and strategies for software and hardware on different levels\n* Review of requirements and specifications\n* Collaboration within the interdisciplinary development team\n* Status reporting to respective project or product leader\nMust Haves:\n* 5+ years of experience working across full product development lifecycles with focus on requirements engineering\n* Background in regulated environments, ideally within IVD or medical device development\n* Strong requirements engineering experience, including ALM tools and requirement breakdown\u002Fstructuring\n* Certifications such as CPRE\u002FIREB, CCBA\u002FIIBA, or INCOSE are advantageous\n* Experience with requirement analysis, test case creation, test execution, and defect lifecycle management\n* Understanding of the V-model\n* Strong analytical thinking, problem-solving, and ability to balance big-picture and detail-oriented work\n* Experience moderating and collaborating with multidisciplinary stakeholders and teams\n* Strong communication skills, autonomous working style, and pragmatic mindset\n* Fluent English and German are required\nReference Nr.: 924973\nRolle: Requirement engineer Hardware \u002F Software\nIndustrie: Pharma\nLocation: Rotkreuz\nPensum: 100%\nStart: ASAP (31.08.2026)\nDuration: 12+ months\nDeadline: 03\u002F06\u002F2026\nIf this position has piqued your interest, please send us your complete resume. If this position does not quite match your profile and you would like to receive other positions directly, you can also send us your resume via this ad or to jobs[at]itcag[dot]com.\nContact us for more information about our company, our positions, or our attractive payroll-only program: +41 41 760 77 01.\nAbout us:\nITech Consult is an ISO 9001:2015-certified Swiss company with offices in Germany and Ireland. ITech Consult specializes in placing highly qualified candidates for temporary staffing in the fields of IT, life sciences, and engineering. We offer temporary staffing and payroll services. This is free of charge for our candidates, and we do not charge any additional fees for payroll services.\nApply Now\n\nIndustry\nPharmaceuticals\nLocation\nZug\nType\ntemporary\n\nE-Mail: service@itcag.com","Requirements Engineer Hardware\u002FSoftware für medizinische Diagnostikgeräte","Wir suchen einen erfahrenen Requirements Engineer für die Entwicklung von Hardware- und Software-Anforderungen im Bereich medizinischer Diagnostikinstrumente. Die Position ist Teil eines interdisziplinären F&E-Teams, das für die Forschung und Entwicklung von Systemen im Near Patient Care Portfolio verantwortlich ist.\n\nAls Requirements Engineer definieren Sie technische Anforderungen für Diagnostikgeräte basierend auf Geschäfts- und Kundenanforderungen sowie Risikobewertungen. Sie arbeiten mit der EARS-Methodik (Easy Approach to Requirements Syntax) und tragen zur Entwicklung von Requirements Engineering-Konzepten und -strategien für Software und Hardware auf verschiedenen Ebenen bei. Zu Ihren Aufgaben gehören die Überprüfung von Anforderungen und Spezifikationen, die Zusammenarbeit im interdisziplinären Entwicklungsteam sowie die Statusberichterstattung an Projekt- oder Produktleiter.\n\nWir erwarten mindestens 5 Jahre Erfahrung in vollständigen Produktentwicklungszyklen mit Fokus auf Requirements Engineering, idealerweise in regulierten Umgebungen wie In-Vitro-Diagnostik oder Medizingeräteentwicklung. Fundierte Kenntnisse in Requirements Engineering, einschließlich ALM-Tools und Anforderungsstrukturierung, sind essentiell. Zertifizierungen wie CPRE\u002FIREB, CCBA\u002FIIBA oder INCOSE sind von Vorteil.\n\nSie verfügen über Erfahrung in Anforderungsanalyse, Testfall-Erstellung und Defekt-Lifecycle-Management sowie ein tiefes Verständnis des V-Modells. Starkes analytisches Denken, Problemlösungsfähigkeiten und die Fähigkeit, sowohl das große Ganze als auch Details im Blick zu behalten, zeichnen Sie aus. Fließende Deutsch- und Englischkenntnisse sowie ein autonomer Arbeitsstil mit pragmatischer Denkweise runden Ihr Profil ab.","en","924973","https:\u002F\u002Fwww.itcag.com\u002Fjobs\u002Frequirement-engineer-8094\u002F",{"items":38},[39,58,69,93,114,123,140,155,174,188,200,215,229,242,254],{"id":40,"slug":41,"title":42,"skills":43,"budget":21,"duration":21,"location":53,"onsitePercent":54,"contractType":55,"foundAt":56,"category":57},6262,"softwareentwickler-c-medizintechnik-mwd","Softwareentwickler C++ Medizintechnik (m\u002Fw\u002Fd)",[44,45,46,47,48,49,50,29,51,52],"C++","C#","C","CAN-Bus","Softwarearchitektur","Softwareentwicklung","Unit-Tests","Elektrotechnik","SCRUM","Jena",50,"contracting","2026-05-27T11:28:50+00:00",{"id":27,"slug":28,"label":29},{"id":59,"slug":60,"title":61,"skills":62,"budget":21,"duration":21,"location":66,"onsitePercent":21,"contractType":55,"foundAt":67,"category":68},6225,"requirement-engineer-hardwaresoftware-mfd","Requirement engineer Hardware\u002FSoftware (m\u002Ff\u002Fd)",[8,18,17,63,64,65,16,19,20],"System Development","ALM tools","Medical Devices","Zug","2026-05-27T10:06:13+00:00",{"id":27,"slug":28,"label":29},{"id":70,"slug":71,"title":72,"skills":73,"budget":21,"duration":88,"location":89,"onsitePercent":90,"contractType":55,"foundAt":91,"category":92},6186,"senior-qa-compliance-expert-2","Senior QA Compliance Expert",[74,75,76,77,78,79,80,81,82,83,84,85,86,87],"GMP","Quality Assurance","Compliance","Deviation Management","CAPA","Change Control","EU-GMP-Leitfaden","ICH-Richtlinien","TrackWise Digital","SAP","S4 HANA","Pharmazie","Chemie","Biologie","11. Mai 2026 bis 31. März 2027","München",20,"2026-05-27T08:11:21+00:00",{"id":27,"slug":28,"label":29},{"id":94,"slug":95,"title":96,"skills":97,"budget":21,"duration":22,"location":23,"onsitePercent":21,"contractType":24,"foundAt":112,"category":113},6181,"msat-engineer-process-management-2","MSAT Engineer Process Management",[98,99,100,76,101,102,83,77,103,104,105,106,107,108,109,110,111],"Process Management","Product Development","GxP","Quality Management","Root Cause Analysis","Process Optimization","Regulatory Compliance","Audit Readiness","Biotechnology","Biology","Chemistry","Material Science","Mechanical Engineering","Electrical Engineering","2026-05-27T07:36:42+00:00",{"id":27,"slug":28,"label":29},{"id":115,"slug":116,"title":96,"skills":117,"budget":21,"duration":22,"location":23,"onsitePercent":119,"contractType":120,"foundAt":121,"category":122},6167,"msat-engineer-process-management",[118,99,100,76,101,102,83,77,103,19,20],"Process Development",100,"permanent","2026-05-27T07:21:17+00:00",{"id":27,"slug":28,"label":29},{"id":124,"slug":125,"title":126,"skills":127,"budget":21,"duration":21,"location":137,"onsitePercent":119,"contractType":55,"foundAt":138,"category":139},5958,"product-manager-mwd","Product Manager (m\u002Fw\u002Fd)",[128,129,130,131,132,29,133,134,135,136],"Produktmanagement","Marketing","R&D","Vertrieb","Qualitätsmanagement","Wirtschaftswissenschaften","Gesundheitsmanagement","Wettbewerbsanalysen","Kommunikationsfähigkeit","Raubling","2026-05-26T10:27:10+00:00",{"id":27,"slug":28,"label":29},{"id":141,"slug":142,"title":143,"skills":144,"budget":21,"duration":21,"location":152,"onsitePercent":119,"contractType":55,"foundAt":153,"category":154},5511,"hardwareentwickler-produktbetreuung-medizintechnik-mwd","Hardwareentwickler Produktbetreuung Medizintechnik (m\u002Fw\u002Fd)",[51,145,146,147,148,83,149,29,150,151],"Hardware-Design","Messtechnik","Linux","Python","MS Office","Validierung","Analyse","Erlangen","2026-05-22T14:25:48+00:00",{"id":27,"slug":28,"label":29},{"id":156,"slug":157,"title":158,"skills":159,"budget":21,"duration":21,"location":171,"onsitePercent":119,"contractType":55,"foundAt":172,"category":173},5471,"ingenieur-mwd-qualifizierung-und-validierung","Ingenieur (m\u002Fw\u002Fd) Qualifizierung und Validierung",[160,161,162,74,150,163,164,83,165,166,167,168,151,169,170],"Pharmatechnik","Biotechnologie","Bio-Verfahrenstechnik","Qualifizierung","Windchill","FMEA","IQ","OQ","Testspezifikation","Dokumentation","FAT","Mannheim","2026-05-22T13:27:31+00:00",{"id":27,"slug":28,"label":29},{"id":175,"slug":176,"title":177,"skills":178,"budget":21,"duration":183,"location":184,"onsitePercent":185,"contractType":55,"foundAt":186,"category":187},5295,"freiberuflicher-konstrukteur-3d-zeichnungen","Freiberuflicher Konstrukteur - 3D Zeichnungen",[179,180,181,182,29],"SolidWorks","3D-Konstruktion","Maschinenbau","Konstruktionstechnik","Dezember \u002F Januar 2025","Baden-Württemberg",2,"2026-05-21T16:39:19+00:00",{"id":27,"slug":28,"label":29},{"id":189,"slug":190,"title":191,"skills":192,"budget":21,"duration":21,"location":197,"onsitePercent":54,"contractType":120,"foundAt":198,"category":199},5293,"quality-spezialist-mwd-fuer-die-medizintechnik","Quality Spezialist (m\u002Fw\u002Fd) für die Medizintechnik",[193,194,29,195,132,196],"ISO 13485","Qualitätssicherung","CAPA-Maßnahmen","Audits","Karlsruhe","2026-05-21T16:39:08+00:00",{"id":27,"slug":28,"label":29},{"id":201,"slug":202,"title":203,"skills":204,"budget":21,"duration":21,"location":211,"onsitePercent":212,"contractType":120,"foundAt":213,"category":214},5292,"senior-expert-validation-engineer-mwd","(Senior) Expert Validation Engineer (m\u002Fw\u002Fd)",[205,206,207,208,29,209,132,210],"Validation Engineering","Prozessentwicklung","ISO13485","Lean\u002FSix Sigma","Produktionsprozesse","Englisch","Nordrhein-Westfalen",80,"2026-05-21T16:39:01+00:00",{"id":27,"slug":28,"label":29},{"id":216,"slug":217,"title":218,"skills":219,"budget":225,"duration":21,"location":226,"onsitePercent":54,"contractType":120,"foundAt":227,"category":228},5291,"regulatory-affairs-manager-mwd","Regulatory Affairs Manager (m\u002Fw\u002Fd)",[220,221,193,222,29,223,224,76],"Regulatory Affairs","MDR","FDA","Risikomanagement","Change-Control","80.000 EUR p.a.","Bayern","2026-05-21T16:38:54+00:00",{"id":27,"slug":28,"label":29},{"id":230,"slug":231,"title":232,"skills":233,"budget":239,"duration":21,"location":226,"onsitePercent":54,"contractType":120,"foundAt":240,"category":241},5290,"senior-quality-manager-rd","Senior Quality Manager (R&D)",[101,75,234,235,236,237,193,238,223],"Quality Control","MedTech - MDR","MedTech - ISO13485","ISO 14971","EU MDR","100.000 EUR p.a.","2026-05-21T16:38:50+00:00",{"id":27,"slug":28,"label":29},{"id":243,"slug":244,"title":245,"skills":246,"budget":251,"duration":21,"location":226,"onsitePercent":54,"contractType":120,"foundAt":252,"category":253},5289,"quality-manager-mwd","Quality-Manager (m\u002Fw\u002Fd)",[101,75,234,235,236,247,248,249,250,196],"Six-Sigma","LEAN","8D","Qualitätsmanagementsystem","90.000 EUR p.a.","2026-05-21T16:38:43+00:00",{"id":27,"slug":28,"label":29},{"id":255,"slug":256,"title":257,"skills":258,"budget":262,"duration":21,"location":184,"onsitePercent":54,"contractType":120,"foundAt":263,"category":264},5288,"head-of-quality-assurance-mwd","Head of Quality Assurance (m\u002Fw\u002Fd)",[75,101,235,236,259,193,260,132,261],"ISO 9001","Führungserfahrung","Medizinprodukte","110.000 EUR p.a.","2026-05-21T16:38:34+00:00",{"id":27,"slug":28,"label":29}]