{"id":760633,"url":"https://alion.io/job/xeltis-senior-manufacturing-engineer","title":"Senior Manufacturing 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":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","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":57000,"max_usd":97000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":73},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false},{"name":"Statistical Process Control","optional":false}],"status":"live","first_seen_at":"2026-08-13T15:33:52Z","employer_posted_date":"2026-08-13","last_verified_at":"2026-10-23T21:05:44Z","board_verified":true,"closed_at":null,"days_open":71,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":71},"description":"Turn a CE-marked breakthrough into a manufacturing line.\nXeltis builds regenerative cardiovascular devices: implants engineered to be gradually restored by the patient’s own living tissue. In April 2026 our lead device, aXess™, reached CE mark. We are now moving from clinical-stage development into commercial-scale production, and that transition is the single most important thing happening in the company right now.\nThat is the job.\nYou will own the industrialisation of a device that has never been made at commercial volume before. Not maintaining a mature line. Building one.\nKey Responsibilities\nManufacturing Scale-Up & Process Development\nLead manufacturing process scale-up activities to support increased production volumes.\n\nDevelop and implement scalable manufacturing solutions.\n\nDrive process optimisation initiatives to improve efficiency and reproducibility.\n\nEstablish robust process control strategies that ensure consistent product quality.\n\nTechnical Leadership\nProvide technical guidance and mentoring to manufacturing engineers and technicians.\n\nLead cross-functional problem solving and decision-making activities.\n\nCollaborate closely with R&D, Quality, Validation, and Operations teams to align manufacturing goals and priorities.\n\nAct as a subject matter expert on manufacturing process performance and capability.\n\nValidation & Regulatory Compliance\nLead manufacturing validation activities, including IQ, OQ, and PQ protocols.\n\nSupport internal audits, external inspections, and regulatory submissions.\n\nEnsure manufacturing documentation, procedures, and controls comply with GMP and quality system requirements.\n\nMaintain focus on product quality, patient safety, and regulatory readiness.\n\nContinuous Improvement\nIdentify opportunities to improve manufacturing performance and process capability.\n\nReduce process variability, waste, and operational inefficiencies.\n\nImplement Lean Manufacturing and continuous improvement methodologies where appropriate.\n\nDrive initiatives that enhance yield, productivity, and cost efficiency.\n\nTechnology Transfer & Industrialisation\nLead the transfer of new products and processes from R&D into manufacturing.\n\nDevelop manufacturing readiness strategies for new technologies.\n\nSupport equipment selection, process development, and industrialisation projects.\n\nEnsure successful integration of innovative technologies into routine manufacturing operations.\n\nTroubleshooting & Risk Management\nLead investigations into process deviations and manufacturing issues.\n\nConduct root cause analyses using structured problem-solving methodologies.\n\nDevelop and implement risk mitigation strategies.\n\nSupport rapid response activities to minimise production disruptions\n\nWhat You'll Bring\nEssential Qualifications & Experience\nBachelor’s or Master’s degree in manufacturing engineering, Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Biotechnology, or a related discipline.\n\nSignificant experience (7+) in manufacturing engineering within a regulated industry such as medical devices, biotechnology, pharmaceuticals, or life sciences.\n\nProven experience supporting manufacturing scale-up and process optimisation.\n\nStrong understanding of GMP, process validation, and quality management systems.\n\nExperience leading cross-functional engineering projects and technical improvement initiatives.\n\nDemonstrated success in technology transfer and industrialisation projects.\n\nTechnical Expertise\nProcess development and optimisation\n\nManufacturing scale-up and technology transfer\n\nProcess validation (IQ/OQ/PQ)\n\nRoot cause analysis and troubleshooting\n\nStatistical process control and process capability analysis\n\nRisk assessment methodologies\n\nLean Manufacturing and continuous improvement techniques\n\nGMP and regulated manufacturing environments\n\nSoft Skills & Leadership Attributes\nWe are looking for an individual who combines strong technical expertise with outstanding leadership and collaboration skills:\nExcellent analytical and problem-solving abilities.\n\nStrong communication and stakeholder management skills.\n\nAbility to influence and lead across multidisciplinary teams.\n\nA proactive and structured approach to identifying and resolving technical challenges.\n\nStrong organisational and project management capabilities.\n\nPassion for continuous improvement and operational excellence.\n\nAbility to mentor and develop colleagues while fostering a collaborative culture.\n\nReady?\nApply below! We review on a rolling basis and move quickly for the right person.","description_format":"text","description_chars":4545,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology"],"lifecycle":[{"event":"open","at":"2026-09-11T18:26:45Z"}],"visa":[],"liveness":{"score":19,"band":"cold","label":"Long shot","p_open":1,"p_active":0.515,"p_room":0.36,"age_days":70,"expected_fill_days":36,"reasons":["conf:1","win:tail","crowd:"],"computed_at":"2026-10-23T05:54:15Z"},"pay":null,"html_url":"https://alion.io/job/xeltis-senior-manufacturing-engineer","json_url":"https://alion.io/job/xeltis-senior-manufacturing-engineer.json","meta":{"generated_at":"2026-10-23T22:32:31Z","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":5348,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-24T00:00:00Z"}},"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-senior-manufacturing-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-senior-manufacturing-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-senior-manufacturing-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-senior-manufacturing-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fxeltis-senior-manufacturing-engineer"}]}