{"id":2271456,"url":"https://alion.io/job/ambu-senior-biosafety-sustainability-engineer-i","title":"Senior Biosafety & Sustainability Engineer I","company":{"id":2093467,"name":"Ambu","domain":"ambu.com","url":"https://alion.io/company/ambu-com","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Career sitemap","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["George Town, Malaysia"],"countries":["MY"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":14000,"max_usd":31000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":8444},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Excel","optional":false}],"status":"live","first_seen_at":"2026-10-11T07:28:29Z","employer_posted_date":"2026-10-11","last_verified_at":"2026-10-26T11:24:42Z","board_verified":true,"closed_at":null,"days_open":15,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":15},"description":"Ambu A/S is currently looking for a Senior Biosafety & Sustainability Engineer I to be based in our Global Hub, Penang. You will be reporting to the Section Manager, Biosafety & Sustainability.\nKey responsibilities\nYour main responsibilities will include:\nPrepare biological evaluation report, toxicological risk assessment, biological equivalence report, FDA 510k submission and material compatibility assessment.\nSupport the biological safety and material compliance evaluation of medical devices throughout the product lifecycle, including risk assessment.\nPlan, execute, and interpret biological and chemical assessments.\nContribute to project planning by identifying biosafety-related activities, risks, dependencies, testing needs, and timelines for product development and change projects.\nCollaborate with cross-functional teams and external partners to support project execution, regulatory submissions, audits, and customer inquiries.\nMonitor and interpret relevant regulations, standards (ISO 10993, ISO 18562), and industry developments related to medical device safety, materials, and chemical compliance (REACH, RoHS, CLP).\nSupport the collection, review, and management of product sustainability data and documentation to ensure accuracy and completeness throughout the product lifecycle.\nEvaluate product, material, and manufacturing changes for potential impacts on sustainability-related documentation and requirements, and support implementation of necessary updates.\nSuggested candidate profile\nSkills and experiences can be earned in many different ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you:\nBachelor's or Master's degree in Polymer Science, Polymer Engineering, Materials Science, Materials Chemistry, Chemical Engineering, Toxicology, Biomedical Engineering, or a related scientific discipline.\nKnowledge of medical device regulations and standards such as ISO 10993, ISO 18562, ISO 14971, ISO 13485, FDA guidance, REACH, and RoHS.\nUnderstanding of polymer and material technologies commonly used in medical devices.\nFamiliarity with material characterization, chemical composition, toxicological risk assessment, chemical characterization, or analytical testing.\nAbility to evaluate and interpret technical, scientific, and regulatory information from multiple sources.\nRelevant experience from medical device or pharmaceutical company.\nStrong analytical and problem-solving skills.\nExcellent written and verbal communication skills in English.\nInterested in sustainability\nGood with excel skills and AI skills\nAble to work effectively in a global, cross-functional environment.\nAmbu - a visionary and international workplace where your efforts matter Ambu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us you will get the opportunity to work in an international head office with an informal working environment. We offer great opportunities for personal development. Furthermore, we offer a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.","description_format":"text","description_chars":3377,"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":[{"language":"English","level":"All levels","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Medical Supplies & Consumables"],"lifecycle":[{"event":"open","at":"2026-10-11T07:28:29Z"}],"visa":[],"liveness":{"score":30,"band":"fade","label":"Fading","p_open":1,"p_active":0.659,"p_room":0.45,"age_days":14,"expected_fill_days":8,"reasons":["conf:2","velocity","win:tail","comp:brand"],"computed_at":"2026-10-26T05:57:25Z"},"pay":null,"html_url":"https://alion.io/job/ambu-senior-biosafety-sustainability-engineer-i","json_url":"https://alion.io/job/ambu-senior-biosafety-sustainability-engineer-i.json","meta":{"generated_at":"2026-10-26T11:46:12Z","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":16030,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-27T00:00:00Z"}},"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":2093467},"rest":"https://alion.io/mcp/rest/get_company?id=2093467"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fambu-senior-biosafety-sustainability-engineer-i"},{"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%2Fambu-senior-biosafety-sustainability-engineer-i"},{"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%2Fambu-senior-biosafety-sustainability-engineer-i"},{"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/ambu-senior-biosafety-sustainability-engineer-i\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fambu-senior-biosafety-sustainability-engineer-i"}]}