[{"author":[{"id":"47565","orcid":"0000-0001-5765-971X","first_name":"Iris","last_name":"Gräßler","full_name":"Gräßler, Iris"},{"full_name":"Pfeifer, Jan Niklas","first_name":"Jan Niklas","last_name":"Pfeifer","id":"62841"},{"full_name":"Trost, Denis","last_name":"Trost","first_name":"Denis"}],"publication_identifier":{"issn":["2334-5837"]},"year":"2026","title":"RegPLM – A method for the application of regulation-centered PLM platforms","intvolume":"        36","publication_status":"published","date_updated":"2026-09-18T08:56:11Z","language":[{"iso":"eng"}],"doi":"https://doi.org/10.1002/iis2.70264","issue":"1","publication":"INCOSE International Symposium","abstract":[{"text":"Approval of products in safety-sensitive areas, such as medical technology, requires considerable effort. Companies must comply with numerous regulations for such product approvals. This results in requirements for processes, methods, tools and organizations throughout the product life cycle. A proven approach to handling regulatory requirements is the application of product lifecycle management (PLM) platforms. Applying PLM platforms (e.g. Teamcenter, 3DExperience) poses challenges in designing compliant processes as well as adapting methods and tools. For example, in medical technology, ISO 13485 specifies an industry-specific product engineering process. The exemplary adaptations of requirements engineering methods and related support – e.g. MBSE including Requirements Diagrams – are not intuitively apparent. Existing literature primarily regards these regulation-related challenges as boundary conditions, offering only vague operational solutions. Companies struggle to align PLM processes with regulatory requirements, yet few methods exist to support this integration. In this paper, a method is proposed that supports the application of regulation-centered PLM platforms and reduces effort in product approvals. The method is developed by applying a five-step approach. Existing literature on process models for applying PLM platforms is identified (1). The identified approaches are then analyzed to determine whether and to what extent they consider regulations in applying PLM platforms (2). Based on identified partial solutions from literature and findings from industry workshops, a new method is developed (3). The method comprises strategic level, process level, data level, pilot level, and operation level. Validation is conducted within a German medical technology company, containing proof of applicability determined through a pilot project (4) and proof of concept achieved through interviews (5). The method is applied to regulation-centered PLM for the use case ‘requirements engineering’. The concept is confirmed by experts in terms of applicability and transferability. The method supports engineers in applying regulation-centered PLM platforms, leading to reduced effort.","lang":"eng"}],"date_created":"2026-09-18T08:54:01Z","type":"conference","keyword":["Regulations","Product Lifecycle Management","Requirements Engineering","Model-Based Systems Engineering","medical technology"],"conference":{"end_date":"2026-06-18","location":"Yokohma, Japan","start_date":"2026-06-13","name":"36th Annual INCOSE International Symposium"},"status":"public","publisher":"Wiley","_id":"67174","page":"1641 - 1655","volume":36,"user_id":"62841","citation":{"ieee":"I. Gräßler, J. N. Pfeifer, and D. Trost, “RegPLM – A method for the application of regulation-centered PLM platforms,” in <i>INCOSE International Symposium</i>, Yokohma, Japan, 2026, vol. 36, no. 1, pp. 1641–1655, doi: <a href=\"https://doi.org/10.1002/iis2.70264\">https://doi.org/10.1002/iis2.70264</a>.","apa":"Gräßler, I., Pfeifer, J. N., &#38; Trost, D. (2026). RegPLM – A method for the application of regulation-centered PLM platforms. <i>INCOSE International Symposium</i>, <i>36</i>(1), 1641–1655. <a href=\"https://doi.org/10.1002/iis2.70264\">https://doi.org/10.1002/iis2.70264</a>","chicago":"Gräßler, Iris, Jan Niklas Pfeifer, and Denis Trost. “RegPLM – A Method for the Application of Regulation-Centered PLM Platforms.” In <i>INCOSE International Symposium</i>, 36:1641–55. Yokohama: Wiley, 2026. <a href=\"https://doi.org/10.1002/iis2.70264\">https://doi.org/10.1002/iis2.70264</a>.","short":"I. Gräßler, J.N. Pfeifer, D. Trost, in: INCOSE International Symposium, Wiley, Yokohama, 2026, pp. 1641–1655.","mla":"Gräßler, Iris, et al. “RegPLM – A Method for the Application of Regulation-Centered PLM Platforms.” <i>INCOSE International Symposium</i>, vol. 36, no. 1, Wiley, 2026, pp. 1641–55, doi:<a href=\"https://doi.org/10.1002/iis2.70264\">https://doi.org/10.1002/iis2.70264</a>.","bibtex":"@inproceedings{Gräßler_Pfeifer_Trost_2026, place={Yokohama}, title={RegPLM – A method for the application of regulation-centered PLM platforms}, volume={36}, DOI={<a href=\"https://doi.org/10.1002/iis2.70264\">https://doi.org/10.1002/iis2.70264</a>}, number={1}, booktitle={INCOSE International Symposium}, publisher={Wiley}, author={Gräßler, Iris and Pfeifer, Jan Niklas and Trost, Denis}, year={2026}, pages={1641–1655} }","ama":"Gräßler I, Pfeifer JN, Trost D. RegPLM – A method for the application of regulation-centered PLM platforms. In: <i>INCOSE International Symposium</i>. Vol 36. Wiley; 2026:1641-1655. doi:<a href=\"https://doi.org/10.1002/iis2.70264\">https://doi.org/10.1002/iis2.70264</a>"},"quality_controlled":"1","place":"Yokohama"},{"quality_controlled":"1","citation":{"ieee":"I. Gräßler, J. N. Pfeifer, F. Hintz, and N. Meyrl, “Systems Engineering roles to handle emergent properties and behaviors in complex technical systems,” in <i>INCOSE International Symposium</i>, Dublin, Ireland, 2024, vol. 34, no. 1, pp. 584–598, doi: <a href=\"https://doi.org/10.1002/iis2.13164\">10.1002/iis2.13164</a>.","apa":"Gräßler, I., Pfeifer, J. N., Hintz, F., &#38; Meyrl, N. (2024). Systems Engineering roles to handle emergent properties and behaviors in complex technical systems. <i>INCOSE International Symposium</i>, <i>34</i>(1), 584–598. <a href=\"https://doi.org/10.1002/iis2.13164\">https://doi.org/10.1002/iis2.13164</a>","short":"I. Gräßler, J.N. Pfeifer, F. Hintz, N. Meyrl, in: INCOSE International Symposium, Wiley, 2024, pp. 584–598.","chicago":"Gräßler, Iris, Jan Niklas Pfeifer, Florian Hintz, and Nicolas Meyrl. “Systems Engineering Roles to Handle Emergent Properties and Behaviors in Complex Technical Systems.” In <i>INCOSE International Symposium</i>, 34:584–98. Wiley, 2024. <a href=\"https://doi.org/10.1002/iis2.13164\">https://doi.org/10.1002/iis2.13164</a>.","mla":"Gräßler, Iris, et al. “Systems Engineering Roles to Handle Emergent Properties and Behaviors in Complex Technical Systems.” <i>INCOSE International Symposium</i>, vol. 34, no. 1, Wiley, 2024, pp. 584–98, doi:<a href=\"https://doi.org/10.1002/iis2.13164\">10.1002/iis2.13164</a>.","bibtex":"@inproceedings{Gräßler_Pfeifer_Hintz_Meyrl_2024, title={Systems Engineering roles to handle emergent properties and behaviors in complex technical systems}, volume={34}, DOI={<a href=\"https://doi.org/10.1002/iis2.13164\">10.1002/iis2.13164</a>}, number={1}, booktitle={INCOSE International Symposium}, publisher={Wiley}, author={Gräßler, Iris and Pfeifer, Jan Niklas and Hintz, Florian and Meyrl, Nicolas}, year={2024}, pages={584–598} }","ama":"Gräßler I, Pfeifer JN, Hintz F, Meyrl N. Systems Engineering roles to handle emergent properties and behaviors in complex technical systems. In: <i>INCOSE International Symposium</i>. Vol 34. Wiley; 2024:584-598. doi:<a href=\"https://doi.org/10.1002/iis2.13164\">10.1002/iis2.13164</a>"},"volume":34,"user_id":"62841","publisher":"Wiley","_id":"56108","page":"584-598","conference":{"start_date":"2024-07-02","name":"34th Annual INCOSE International Symposium","location":"Dublin, Ireland","end_date":"2024-07-06"},"status":"public","department":[{"_id":"152"}],"keyword":["Systems Engineering roles","properties","features","emergent phenomena","automotive"],"type":"conference","date_created":"2024-09-11T08:07:26Z","abstract":[{"text":"<jats:title>Abstract</jats:title><jats:p>Engineering projects for complex technical systems such as automobiles demand extensive requirement specifications and corresponding hierarchy levels in system architectures. Especially when considering emergent phenomena, such as total weight or aerodynamics, a closely networked collaboration of discipline‐specific and cross‐disciplinary roles is required. Further, in large organizations with a group structure, resulting functional and non‐functional contents need to be managed by distinct Systems Engineering roles. For example, the role “property manager” takes care of achieving overarching product properties, such as weight or aerodynamics, which cannot be directly fixed, but result from many specifications. This paper proposes new Systems Engineering roles and their application in a German Original Equipment Manufacturer (OEM). For validation, the roles have already been applied in everyday engineering projects at the OEM. The concept proved to be indispensable and transferable to other Systems Engineering projects.</jats:p>","lang":"eng"}],"publication":"INCOSE International Symposium","issue":"1","doi":"10.1002/iis2.13164","language":[{"iso":"eng"}],"intvolume":"        34","publication_status":"published","date_updated":"2024-09-11T08:22:55Z","author":[{"last_name":"Gräßler","orcid":"0000-0001-5765-971X","first_name":"Iris","full_name":"Gräßler, Iris","id":"47565"},{"first_name":"Jan Niklas","last_name":"Pfeifer","full_name":"Pfeifer, Jan Niklas","id":"62841"},{"full_name":"Hintz, Florian","first_name":"Florian","last_name":"Hintz"},{"first_name":"Nicolas","last_name":"Meyrl","full_name":"Meyrl, Nicolas"}],"publication_identifier":{"issn":["2334-5837","2334-5837"]},"title":"Systems Engineering roles to handle emergent properties and behaviors in complex technical systems","year":"2024"},{"citation":{"bibtex":"@article{Kaiser_Wilke_Förster_Köhler_Dumitrescu_2024, title={Evolving Roles in Systems Engineering —‐ Insights from Germany’s Mechanical and Plant Engineering Sector}, volume={34}, DOI={<a href=\"https://doi.org/10.1002/iis2.13216\">10.1002/iis2.13216</a>}, number={1}, journal={INCOSE International Symposium}, publisher={Wiley}, author={Kaiser, Lydia and Wilke, Daria and Förster, Felix and Köhler, Ingmarie and Dumitrescu, Roman}, year={2024}, pages={1413–1428} }","ama":"Kaiser L, Wilke D, Förster F, Köhler I, Dumitrescu R. Evolving Roles in Systems Engineering —‐ Insights from Germany’s Mechanical and Plant Engineering Sector. <i>INCOSE International Symposium</i>. 2024;34(1):1413-1428. doi:<a href=\"https://doi.org/10.1002/iis2.13216\">10.1002/iis2.13216</a>","mla":"Kaiser, Lydia, et al. “Evolving Roles in Systems Engineering —‐ Insights from Germany’s Mechanical and Plant Engineering Sector.” <i>INCOSE International Symposium</i>, vol. 34, no. 1, Wiley, 2024, pp. 1413–28, doi:<a href=\"https://doi.org/10.1002/iis2.13216\">10.1002/iis2.13216</a>.","short":"L. Kaiser, D. Wilke, F. Förster, I. Köhler, R. Dumitrescu, INCOSE International Symposium 34 (2024) 1413–1428.","chicago":"Kaiser, Lydia, Daria Wilke, Felix Förster, Ingmarie Köhler, and Roman Dumitrescu. “Evolving Roles in Systems Engineering —‐ Insights from Germany’s Mechanical and Plant Engineering Sector.” <i>INCOSE International Symposium</i> 34, no. 1 (2024): 1413–28. <a href=\"https://doi.org/10.1002/iis2.13216\">https://doi.org/10.1002/iis2.13216</a>.","ieee":"L. Kaiser, D. Wilke, F. Förster, I. Köhler, and R. Dumitrescu, “Evolving Roles in Systems Engineering —‐ Insights from Germany’s Mechanical and Plant Engineering Sector,” <i>INCOSE International Symposium</i>, vol. 34, no. 1, pp. 1413–1428, 2024, doi: <a href=\"https://doi.org/10.1002/iis2.13216\">10.1002/iis2.13216</a>.","apa":"Kaiser, L., Wilke, D., Förster, F., Köhler, I., &#38; Dumitrescu, R. (2024). Evolving Roles in Systems Engineering —‐ Insights from Germany’s Mechanical and Plant Engineering Sector. <i>INCOSE International Symposium</i>, <i>34</i>(1), 1413–1428. <a href=\"https://doi.org/10.1002/iis2.13216\">https://doi.org/10.1002/iis2.13216</a>"},"status":"public","publisher":"Wiley","_id":"58468","page":"1413-1428","volume":34,"user_id":"15782","issue":"1","publication":"INCOSE International Symposium","abstract":[{"text":"<jats:title>Abstract</jats:title><jats:p>Systems Engineering is developing differently in each sector and region. In German industry, especially in mechanical and plant engineering, Systems Engineering is of major importance. The introduction of Systems Engineering raises the question of which roles and competencies are required. This article examines the evolution of roles in Systems Engineering from a German perspective. Based on a literature review, the evolution of the identified Systems Engineering roles over time is shown, starting with the seminal publication by Sheard in 1996. It points out that only minimal adjustments and occasional role renaming have occurred. However, the review shows a common understanding of essential areas of responsibility within the SE and changes over time. The next step is to examine the current understanding of Systems Engineering roles in the industry. A quantitative analysis of job postings in Germany reveals a diverse interpretation of the term 'Systems Engineer; more than half of the positions cannot be categorized according to the INCOSE definitions. The job postings are used to determine which tasks are associated with the job, how often they occur, and in what combination. The primary responsibilities of systems engineers include creating and managing requirements, architecture processes, validation, and verification processes, and coordinating with customers and stakeholders. Finally, three representative companies from the mechanical and plant engineering sector were selected to analyze existing roles and tasks. From this, a common understanding of tasks and responsibilities is combined and organized into clusters. These are used by the companies to locate and thus derive their roles. The result is in an integrative approach that enables companies, especially in the midsize and medium sectors, to design the introduction in line with stakeholder demands. In summary, the industry's ongoing adaptation necessitates the evolution of Systems Engineering roles and competencies for successful and sustainable development and implementation of systems.</jats:p>","lang":"eng"}],"date_created":"2025-01-31T13:19:03Z","department":[{"_id":"563"}],"type":"journal_article","author":[{"full_name":"Kaiser, Lydia","first_name":"Lydia","last_name":"Kaiser"},{"full_name":"Wilke, Daria","last_name":"Wilke","first_name":"Daria"},{"first_name":"Felix","last_name":"Förster","full_name":"Förster, Felix"},{"full_name":"Köhler, Ingmarie","last_name":"Köhler","first_name":"Ingmarie"},{"id":"16190","full_name":"Dumitrescu, Roman","last_name":"Dumitrescu","first_name":"Roman"}],"publication_identifier":{"issn":["2334-5837","2334-5837"]},"title":"Evolving Roles in Systems Engineering —‐ Insights from Germany's Mechanical and Plant Engineering Sector","year":"2024","intvolume":"        34","publication_status":"published","date_updated":"2025-01-31T13:19:24Z","language":[{"iso":"eng"}],"doi":"10.1002/iis2.13216"}]