{"id":3548294,"url":"https://alion.io/job/xeltis-principal-controls-and-software-engineer","title":"Principal Controls and Software Engineer","company":{"id":690568,"name":"Xeltis","domain":"xeltis.com","url":"https://alion.io/company/xeltis","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Teamtailor","truth_index":null},"role":"Backend","role_family":"Backend","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Eindhoven, Netherlands"],"countries":["NL"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":60000,"max_usd":120000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":21},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-09-04T07:54:23Z","employer_posted_date":"2026-09-04","last_verified_at":"2026-10-31T16:16:46Z","board_verified":true,"closed_at":null,"days_open":57,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":57},"description":"Shape the Future of Regenerative Medicine Manufacturing\nAt Xeltis, we are pioneering transformative medical technologies that enable the body's natural healing processes to create living and durable vascular implants. As we transition from technology development into clinical and commercial-scale manufacturing, we are looking for an experienced Principal Controls & Software Engineer.\nThe Role\nAs Principal Controls & Software Engineer, you will lead the architecture, development and implementation of our advanced control systems and embedded and software applications. You will bring strong knowledge of Computerised System Validation (CSV) and of software verification and validation (V&V).\nThis is a unique opportunity for an experienced Controls & Software Engineer to take ownership of ensuring that our manufacturing/ Shopfloor Control processes are scalable, compliant, reliable, and ready to support global commercialization. The scope also includes our business applications & data architecture such as; SCM, logistics and our azure (middleware) platform.\nWorking with our Business leaders across e.g., Supply Chain Management, Logistics, Engineering, Manufacturing, Quality, R&D and External partners, you will ensure that Xeltis' control systems business applications & data architecture, meet the highest standards of performance, regulatory compliance, and operational excellence.\nKey Responsibilities\nAdvanced control systems and embedded/software applications;\nLead the design and development of control algorithms and software architectures.\n\nDevelop and maintain embedded software, real-time control systems, and automation applications.\n\nDefine system requirements, specifications, and technical standards.\n\nPerform system modelling, simulation, testing, and validation.\n\nIntegrate hardware, software, sensors, actuators, and communication protocols.\n\nTroubleshoot and resolve complex system and software issues.\n\nConduct design reviews and ensure compliance with industry standards and safety regulations.\n\nProvide technical guidance and mentorship to engineering teams.\n\nCollaborate with product management, hardware engineers, manufacturing teams, and customers.\n\nDrive continuous improvement, innovation, and technology roadmaps.\n\nSupport project planning, risk assessment, and resource estimation.\n\nDocument designs, test procedures, and engineering solutions.\n\nAutomation Strategy & Architecture\nDefine and govern the long-term automation and control systems roadmap across manufacturing operations.\nDevelop scalable, modular, and standardised control system architectures across equipment and facilities.\nDrive harmonisation of software platforms, coding standards, and automation best practices.\nEnsure automation solutions support future product and manufacturing expansion.\n\nServe as the Design Authority for automation, controls, software and manufacturing systems within Engineering & Manufacturing, approving architectural decisions and technical standards, and advising on enterprise technology selection together with IT and the relevant function owners.\n\nSoftware Compliance (CSV) & Regulatory Leadership\nAct as the company's subject matter expert for GMP, GAMP, NIS2, software validation, data integrity, and electronic records compliance.\nEnsure control systems, manufacturing software, other business software meet medical device and regulatory requirements.\n\nLead validation activities and support regulatory inspections and audits.\n\nManufacturing Scale-Up & Technology Transfer\nLead the translation of laboratory and R&D processes into robust, automated manufacturing systems.\n\nDrive software automation strategies that improve process reproducibility, product consistency, and manufacturing efficiency.\n\nSupport technology transfer activities from development to commercial production environments.\n\nDigitalisation & Advanced Process Control\nIdentify and implement advanced control strategies to optimise manufacturing performance.\n\nDrive integration of process analytical technologies (PAT), and our application architecture e.g., manufacturing execution systems (MES), and data management platforms.\n\nChampion digital transformation initiatives that enhance operational insight and process understanding.\n\nDevelop the long-term Industry 4.0 roadmap covering cloud integration, advanced analytics and AI-enabled process optimisation.\n\nReliability & Operational Excellence\nEstablish standards for automation system reliability, cybersecurity, maintenance, and lifecycle management.\nDefine and govern OT cybersecurity architecture in accordance with IEC 62443 and corporate cybersecurity policies.\nDevelop strategies to maximise equipment uptime and minimise operational risk.\nLead root cause investigations and continuous improvement efforts relating to automation systems.\n\nTechnical Leadership & Mentoring\nProvide senior technical leadership across multidisciplinary engineering projects.\n\nServe as the primary controls and software technical interface between Engineering, Manufacturing, Quality, and external vendors.\n\nVendor & Systems Integration Management\nDefine automation specifications and standards for equipment suppliers and systems integrators.\n\nEnsure third-party systems integrate seamlessly with Xeltis infrastructure and long-term automation strategy.\n\nOversee vendor performance throughout system design, implementation, and commissioning.\n\nEssential Qualifications & Experience\nMaster's degree or PhD in Automation Engineering, Control Systems Engineering, Software Engineering, Electrical Engineering, or a related discipline.\n\nSignificant experience in industrial automation, control systems, and manufacturing software within regulated industries.\n\nStrong knowledge of Siemens PLC’s, Ignition SCADA, HMI, and industrial control system architectures, programming and debugging.\n\nDemonstrated experience leading automation projects from concept through commissioning and validation.\n\nDeep understanding of GMP, GAMP5, CSV and data integrity requirements.\n\nExperience supporting manufacturing scale-up, technology transfer, and process automation initiatives.\n\nProven ability to establish technical standards and influence engineering strategy across organisations.\n\nExperience managing external automation vendors and systems integrators.\n\nTechnical Expertise\nControl system architecture and design, PLC code development, debugging and Troubleshooting.\n\nIndustrial networking and cybersecurity\n\nManufacturing data management and system integration\n\nAdvanced process control methodologies\n\nMES, historian, and industrial data platforms\n\nSoftware validation and lifecycle management\n\nRegulatory compliance in medical device, pharmaceutical, biotech, or related industries\n\nSoft Skills & Leadership Attributes\nStrategic thinker with the ability to balance long-term vision and practical execution.\n\nStrong leadership and influencing skills across all organisational levels.\n\nExcellent problem-solving and analytical capabilities.\n\nStrong communication skills, capable of translating complex technical concepts for diverse audiences.\n\nHighly organised with the ability to manage multiple priorities in a fast-paced environment.\n\nPassionate about innovation, continuous improvement, and engineering excellence.\n\nWhy Join Xeltis?\nAt Xeltis, you will have the opportunity to make a meaningful impact on a technology that has the potential to transform patient outcomes globally. You will work alongside world-class scientists, engineers, and manufacturing professionals in a collaborative and innovative environment where your expertise will directly influence the future of regenerative medical device manufacturing.\nIf you are excited by the challenge of building scalable, compliant, and cutting-edge manufacturing automation systems in a rapidly growing MedTech company, we would love to hear from you.\nXeltis is an equal opportunity employer. We welcome all qualified applicants and make employment decisions without regard to age, gender, ethnicity, nationality, religion, disability, sexual orientation, or any other characteristic protected by applicable law.\nApply now and help shape the future of regenerative medicine at Xeltis.","description_format":"text","description_chars":8197,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"master","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Information Security","Cardiovascular Devices"],"lifecycle":[{"event":"open","at":"2026-10-30T21:37:46Z"}],"visa":[],"liveness":{"score":25,"band":"fade","label":"Fading","p_open":1,"p_active":0.55,"p_room":0.45,"age_days":56,"expected_fill_days":30,"reasons":["conf:3","win:tail"],"computed_at":"2026-10-31T05:58:55Z"},"pay":null,"html_url":"https://alion.io/job/xeltis-principal-controls-and-software-engineer","json_url":"https://alion.io/job/xeltis-principal-controls-and-software-engineer.json","meta":{"generated_at":"2026-10-31T21:59:01Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":34290,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-01T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":690568},"rest":"https://alion.io/mcp/rest/get_company?id=690568"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fxeltis-principal-controls-and-software-engineer"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fxeltis-principal-controls-and-software-engineer"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fxeltis-principal-controls-and-software-engineer"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/xeltis-principal-controls-and-software-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fxeltis-principal-controls-and-software-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3548294}},{"tool":"search_jobs","arguments":{"company":"xeltis.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3548294},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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