{"id":3130064,"url":"https://alion.io/job/flex-process-validation-engineer-medical-devices","title":"Process Validation Engineer (Medical Devices)","company":{"id":1845316,"name":"Flex","domain":"flex.com","url":"https://alion.io/company/flex-com","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":83,"open_postings":94,"ghost_share":0,"stale_share":0.691,"repost_share":0,"time_to_fill_p50_days":26,"computed_at":"2026-10-25T05:49:26Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Juárez, Mexico"],"countries":["MX"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":24000,"max_usd":59000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":10},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"FMEA","optional":false},{"name":"ISO 13485","optional":false}],"status":"live","first_seen_at":"2026-10-22T00:00:00Z","employer_posted_date":"2026-10-22","last_verified_at":"2026-10-24T17:33:04Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.\nA career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary.\nJob Summary\n\nTo support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a Process Validation Engineer (Medical Devices) located in Juarez South.\nReporting to the Process Engineering Manager, the Process Engineer’s role involves:\nWhat a typical day looks like:\nLead validation activities for manufacturing processes, equipment, and systems, including IQ, OQ, PQ, and TMV studies.\nDevelop, execute, and approve validation protocols and reports in compliance with FDA, ISO 13485, and internal quality requirements.\nSupport New Product Introduction (NPI) activities, ensuring validation deliverables are completed on time.\nEvaluate process changes and determine validation impact assessments and revalidation requirements.\nPerform statistical analysis and capability studies to support process validation and continuous improvement initiatives.\nCollaborate with cross-functional teams including Quality, Manufacturing, Regulatory Affairs, and R&D.\nConduct risk assessments using PFMEA and other risk management tools.\nInvestigate process deviations, nonconformances, customer complaints, and CAPA activities.\nSupport internal, customer, and regulatory audits by providing validation documentation and technical expertise.\nDevelop and maintain validation master plans, protocols, reports, and associated documentation.\nIdentify and implement process improvements that enhance quality, compliance, productivity, and cost efficiency.\nThe experience we’re looking to add to our team:\nBachelor’s degree in engineering (Mechanical, Industrial, Biomedical, Manufacturing, Mechatronics, or related field).\nAdvanced English communication skills.\nMinimum 3-5 years of experience in medical devices, pharmaceutical, or regulated manufacturing environments.\nStrong experience executing and managing IQ, OQ, PQ, and processing validation activities.\nProficiency in statistical tools, process capability studies, and data analysis.\nKnowledge of risk management methodologies, including PFMEA.\nExperience with CAPA, nonconformance investigations, and root cause analysis methodologies.\nStrong project management and cross-functional leadership skills.\nWhat you’ll receive for the great work you provide:\nPantry vouchers\nSaving Fund\nChristmas bonus\nHoliday bonus\nMedical Insurance\nLife Insurance\nEM57\nJob Category\nProduction EngineeringRequired Skills:\nOptional Skills:\nFlex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email  and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).","description_format":"text","description_chars":3598,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":["Health insurance","Life insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health & Medical Electronics","Electronics Manufacturing","Power Supplies & Power Electronics","Contract Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-23T03:23:49Z"}],"visa":[],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":3,"expected_fill_days":26,"reasons":["conf:12","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-10-25T05:49:26Z"},"pay":null,"html_url":"https://alion.io/job/flex-process-validation-engineer-medical-devices","json_url":"https://alion.io/job/flex-process-validation-engineer-medical-devices.json","meta":{"generated_at":"2026-10-26T05:09:30Z","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":6874,"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":1845316},"rest":"https://alion.io/mcp/rest/get_company?id=1845316"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fflex-process-validation-engineer-medical-devices"},{"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%2Fflex-process-validation-engineer-medical-devices"},{"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%2Fflex-process-validation-engineer-medical-devices"},{"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/flex-process-validation-engineer-medical-devices\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fflex-process-validation-engineer-medical-devices"}]}