{"id":3304589,"url":"https://alion.io/job/biointellisense-manufacturing-engineer-medical-device","title":"Manufacturing Engineer (Medical Device)","company":{"id":3134766,"name":"BioIntelliSense","domain":"biointellisense.com","url":"https://alion.io/company/biointellisense","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":null},"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":["Golden, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":80000,"max":120000,"currency":"USD","period":"year","gross":null,"usd_annual":120000},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"ISO 13485","optional":false},{"name":"Verification & Validation","optional":false},{"name":"Power Apps","optional":true},{"name":"Power BI","optional":true},{"name":"Python","optional":true},{"name":"SQL","optional":true}],"status":"live","first_seen_at":"2026-10-26T22:33:03Z","employer_posted_date":"2026-10-26","last_verified_at":"2026-11-03T05:00:48Z","board_verified":true,"closed_at":null,"days_open":7,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":7},"description":"About The Role\nWe are looking for a Manufacturing Engineer to manage verifications and validations of our devices and software tools. This role will also collaborate internally with cross functional teams and externally with our manufacturing partners to ensure compliance, quality, and efficiency in our manufacturing process, engineering documentation and drawings, design transfers, etc.\nWe are open to this role being at the Engineer or Lead level based on experience.\nWhat You'll Be Doing\nLead continuous improvement initiatives to enhance manufacturing efficiency through the development and optimization of tools, processes, and software\nSupport manufacturing line setup and optimization at contract manufacturing (CM) partners, including line balancing, cycle-time reduction, and continuous improvement initiatives to increase production efficiency and throughput\nSupport make-versus-buy evaluations and, when transitioning manufacturing or packout in-house, help develop and execute the transition plan, including process validation, equipment and resource requirements, and production readiness\nManage verifications and validations of new products/devices/tools releases\nGenerate protocols and SOPs for final testing, handling, and reporting\nSupport R&D systems testing\nConduct systems and software validation\nSupport root cause investigations\nAct as the main liaison between Operations, R&D, Product and Regulatory / Quality teams and our external manufacturing partners\nEnsure manufacturing processes and quality criteria meet BioIntelliSense’s standards and that procedures comply with safety and environmental regulations\nDevelop and test effective automated and manual systems\nOrganize and manage manufacturing workflows and resources\nCollaborate with other engineers, contractors, and suppliers\nWhat We Are Looking For\nBachelor’s degree in Mechanical, Electrical, BioMedical, Manufacturing, Industrial, or a related engineering discipline\n3-8 years’ experience in a Manufacturing or Industrial engineering environment with offsite/offshore manufacturing partners\nMedical device manufacturing experience working within a quality management system (ISO 13485, FDA 21 CFR Part 820)\nExperience with verification and validations of medical devices, software/tools, and systems\nProven ability to perform root cause analysis\nExcellent communication and project management skills\nKnowledge of manufacturing processes, fabrication methods, tool design and quality assurance techniques\nFamiliarity with manufacturing equipment and quality assurance technique\nPreferred Qualifications\nMaster’s degree in Engineering or an MBA\nDemonstrated experience building software tools to drive Lean or efficiency improvements (e.g., Python, SQL, Power BI, Power Apps, or similar), from defining requirements through deployment and user adoption\nExperience mentoring or training interns, junior engineers, or technicians\nLean Six Sigma Green Belt or Black Belt\nExperience with electronics/PCBA or high-volume electronics assembly\nExperience integrating tools with MES/ERP systems or manufacturing test data, and validating software used in production\nAbility to travel domestically and internationally to manufacturing partners","description_format":"text","description_chars":3220,"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":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health & Medical Electronics","Patient Monitoring"],"lifecycle":[{"event":"open","at":"2026-10-27T00:53:26Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 1","filings_12m":1,"filings_prev_12m":1,"green_card_filings_12m":0,"median_offered_wage_usd":92500,"route":null,"cap_exempt":false,"checked_at":"2026-10-29T16:27:21+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":7,"expected_fill_days":25,"reasons":["conf:0","win:early"],"computed_at":"2026-11-03T05:54:40Z"},"pay":{"stated_usd_annual":120000,"is_top_pay":true},"html_url":"https://alion.io/job/biointellisense-manufacturing-engineer-medical-device","json_url":"https://alion.io/job/biointellisense-manufacturing-engineer-medical-device.json","meta":{"generated_at":"2026-11-03T06:15:35Z","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":8702,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-04T00:00:00Z"}},"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":3134766},"rest":"https://alion.io/mcp/rest/get_company?id=3134766"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fbiointellisense-manufacturing-engineer-medical-device"},{"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%2Fbiointellisense-manufacturing-engineer-medical-device"},{"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%2Fbiointellisense-manufacturing-engineer-medical-device"},{"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/biointellisense-manufacturing-engineer-medical-device\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fbiointellisense-manufacturing-engineer-medical-device"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3304589}},{"tool":"search_jobs","arguments":{"company":"biointellisense.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3304589},"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. Docs: https://alion.io/developers"}}