{"id":964702,"url":"https://alion.io/job/materialise-senior-process-validation-engineer-standard-devices-cmf","title":"Senior Process Validation Engineer – Standard Devices (CMF)","company":{"id":54388,"name":"Materialise","domain":"materialise.com","url":"https://alion.io/company/materialise","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","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":"explicit","locations":["Leuven, Belgium"],"countries":["BE"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":60000,"max_usd":121000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":10},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-09-16T13:12:41Z","employer_posted_date":"2026-09-16","last_verified_at":"2026-11-13T00:58:33Z","board_verified":true,"closed_at":null,"days_open":57,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":57},"description":"At Materialise Medical, we believe that better healthcare starts with solutions designed around the individual patient. If you’re passionate about bringing personalized care to every patient, you’ll love being a part of this team. Through the technology we develop, researchers, engineers, and clinicians are revolutionizing personalized treatment - helping improve and save lives daily.\nSenior Process Validation Engineer - Standard Devices (CMF)\nLocation: Leuven, Belgium (HQ), with recurring extended travel to Rio Claro, Brazil\nAbout the role\nMaterialise is a worldwide leader in patient-specific medical devices. In the Cranio-Maxillofacial (CMF) domain, we are scaling a second growth engine: standard, non-patient-specific implants and instruments, together with Materialise Brazil in Rio Claro.\nTo support this growth and ensure consistent process quality and control across both sites, we are looking for a Senior Process Validation Engineer to become the engineering link between our HQ and Brazil’s development and manufacturing sites.\nWhat you will be doing\nYou are a member of a cross-functional engineering team working on the development, validation and operational release of new and improved products and manufacturing processes, in close collaboration with our suppliers.\n\nYou translate product and process requirements into validation strategies and process control programs, in close collaboration with product development, R&D, biosafety, quality and regulatory teams in both Leuven and Brazil.\n\nYou take up a leading role in qualifying equipment, validating software, and supporting the technology transfer of processes as production responsibilities grow in Materialise Brazil.\n\nYou monitor process performance, investigate deviations, and drive corrective and preventive actions across both sites.\n\nYou spend recurring, extended periods on-site in Brazil to align the way of working and strengthen collaboration between both teams.\n\nYour profile\nYou have several years of hands-on experience in process validation within the medical device industry (or a comparably regulated environment).\n\nYou are familiar with manufacturing processes such as milling, turning, anodizing, passivation, welding, laser cutting and/or ultrasonic cleaning.\n\nYou are fluent in Portuguese and English - able to work independently and build trust with colleagues in both languages.\n\nYou are willing to travel to and work from Brazil for extended periods on a recurring basis.\n\nYou hold a master’s degree in Engineering (Industrial, Mechanical, Materials, Biomedical or related), or equivalent through experience.\n\nYou are familiar with ISO 13485; knowledge of RDC 665 / ANVISA GMP and FDA concepts is a plus.\n\nYou have a solid grasp of statistics and experience with risk analysis methodologies such as FMEA.\n\nYou have strong communication skills and a proactive, quality-driven mindset, with good judgement on priorities.\n\nWhat we offer\nA high-impact role connecting Materialise’s HQ Engineering team with growing activities in Materialise Brazil.\n\nA position based at our Leuven HQ, combined with recurring extended assignments in Materialise Brazil.\n\nClose collaboration with an international team spanning process engineering, R&D, quality and operations.\n\nA growth trajectory: as the scope of the role develops, so does the range of your responsibilities across our global operations.\n\nWhat’s waiting for you\nWork that matters \nThe technology we build at Materialise pushes the boundaries. You’ll find pride in building something that matters, whether you designed it, printed it, or shipped it. No matter your role, we unlock new possibilities to build a better and healthier world every day.\nAt Materialise, we expect you to think about the customer, not just the task. You push for better solutions and care about the difference your work makes.\nA people-centered space \nWhen you join Materialise, you join a group of colleagues invested in you, not just your work. From your own team to a department across the world, you’ll find a sense of belonging with people who help without being asked, challenge you, and have your back.\nAt the same time, we expect you to invest in the people around you - not just your own work - to make the group stronger than the sum of its parts.\nAn environment of trust \nAs a company of innovators, we know how crucial autonomy is in your work. When we hire you, we trust in your expertise, giving you space to organize your tasks, work flexibly, and make your own calls.\nAt Materialise, we expect you to deliver on that trust and keep your commitments.\nA career ready to build \nWhen you see opportunities for your career to grow at Materialise, we encourage you to go for them. People shape a fulfilling career at their own pace here.\nAt Materialise, we expect you to take initiative in your own development. Don’t wait for someone else to plan your career. Step into the space and make it count.\nMake a difference together with the Medical team.","description_format":"text","description_chars":4988,"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":[{"language":"Portuguese","level":"Advanced (C1)","optional":false},{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":[],"hiring_locations":[{"name":"Belgium","iso":"BE","kind":"country"},{"name":"Brazil","iso":"BR","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["CAD, PLM & BIM Software","3D Printers & Additive Manufacturing","Orthopedic & Spine Implants"],"lifecycle":[{"event":"open","at":"2026-09-16T13:12:41Z"}],"visa":[],"liveness":{"score":48,"band":"ok","label":"Likely open","p_open":1,"p_active":0.866,"p_room":0.55,"age_days":56,"expected_fill_days":50,"reasons":["conf:1","velocity","win:tail"],"computed_at":"2026-11-12T10:38:37Z"},"pay":null,"html_url":"https://alion.io/job/materialise-senior-process-validation-engineer-standard-devices-cmf","json_url":"https://alion.io/job/materialise-senior-process-validation-engineer-standard-devices-cmf.json","meta":{"generated_at":"2026-11-13T08:38:17Z","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":17869,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-14T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"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":54388},"rest":"https://alion.io/mcp/rest/get_company?id=54388"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fmaterialise-senior-process-validation-engineer-standard-devices-cmf"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"free","price":{"credits":0,"usd":0},"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%2Fmaterialise-senior-process-validation-engineer-standard-devices-cmf"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"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%2Fmaterialise-senior-process-validation-engineer-standard-devices-cmf"},{"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/materialise-senior-process-validation-engineer-standard-devices-cmf\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fmaterialise-senior-process-validation-engineer-standard-devices-cmf"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":964702}},{"tool":"search_jobs","arguments":{"company":"materialise.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":964702},"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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