{"id":188007,"url":"https://alion.io/job/nextern-manufacturing-engineer-ii-2nd-shift","title":"Manufacturing Engineer II (2nd Shift)","company":{"id":6892,"name":"Nextern","domain":"nextern.com","url":"https://alion.io/company/nextern","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workable","truth_index":{"grade":"B","score":80,"open_postings":5,"ghost_share":0,"stale_share":0.6,"repost_share":0,"time_to_fill_p50_days":69,"computed_at":"2026-10-27T05:46:45Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Maple Grove, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":60000,"max_usd":110000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":4330},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-09-01T00:00:00Z","employer_posted_date":"2026-09-01","last_verified_at":"2026-10-27T15:21:10Z","board_verified":true,"closed_at":null,"days_open":56,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":56},"description":"At Nextern, we inspire with passion, impact with significance, and act with integrity.. Nextern partners with OEMs, clinicians, and innovators to design, develop, and manufacture world-class medical devices across the full product lifecycle. From single-use disposables to fully integrated systems to precision components, our teams work as an extension of yours to solve patient needs and improve lives worldwide.\nThe Manufacturing Quality Engineer ensures that manufacturing programs meet applicable quality, regulatory, and customer requirements by providing quality oversight, driving compliant execution, and supporting continuous improvement across the product lifecycle.\nThis role provides operational quality input and deliverables for manufacturing programs throughout the product lifecycle. Manufacturing Quality Engineers also support development activities as programs prepare to launch into commercial manufacturing, including manufacturing readiness, audits, and clinical builds. This support helps ensure a smooth transition while maintaining accurate and compliant Design History Files. All engineering functions are responsible for compliance with the Quality System and applicable regulations and standards, continuous improvement, and professional interaction with Nextern customers, as needed.\nResponsibilities:\nAuthor and approve SOPs, work instructions, and forms. Support internal audits and maintain inspection readiness across the quality system.\nCompile and trend quality metrics to identify systemic issues. Present actionable insights to leadership and drive implementation of corrective and preventive actions.\nOversee incoming inspection report approval. Disposition nonconforming materials and coordinate supplier corrective actions to address recurring quality issues.\nProvide quality oversight for IQ/OQ/PQ qualification activities. Review and approve protocols, reports, and change orders. Evaluate regulatory impact of equipment changes prior to implementation.\nManage nonconformances and CAPAs from initiation through effectiveness verification. Lead root cause analysis using structured methods (5-Why, fishbone). Trend data and report findings at management review.\nAct as the quality point of contact for production; review batch records and travelers for GMP compliance; support line clearances, first-article inspections, and process change reviews.\nDraft, collaborate, and approve product and engineering work orders.\nCreate and maintain up-to-date product Design History Files (DHF).\nAdvise project teams and lead by example in best practices for Quality and Regulatory Compliance.\nOwn, review, and approve changes to ensure impacts and resulting action or implementation decisions are properly documented and executed.\nReceive, investigate, and document product complaints, interacting with customers as applicable.\nSupport audits as Subject Matter Expert (SME) for QMS processes and product DHFs.\nDrive Product Lifecycle Management (PLM) architecture and changes, as needed.\nRequirements\nQUALIFICATIONS:\nBachelor’s degree in a life science discipline, or an equivalent combination of education and experience.\n5+ years of experience in medical device development or manufacturing, or 3+ years of experience in a Design Assurance or Quality Engineering role.\nExperience working within quality systems defined by 21 CFR Part 820 and ISO 13485.\nDemonstrated technical expertise and leadership in quality.\nHigh attention to detail, organization, and accuracy.\nDemonstrated ability to think creatively and propose practical, novel solutions.\nStrong ability to communicate in writing and verbally within and across disciplines and organizational structures.\nSalary Range:\n$80,000 to $100,000 depending on skills and experience\nBenefits\nHealth Care Plan (Medical, Dental & Vision)\nRetirement Plan with Company Match\nPaid Time Off, Personal Days, AND Birthday Holiday!\nLifetime Membership Subsidy and Wellness Resources\nLife Insurance (Basic, Voluntary & AD&D)\nFamily Leave (Maternity, Paternity)\nShort-Term & Long-Term Disability\nTaco Thursdays!!!\nNextern is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.","description_format":"text","description_chars":4469,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":["Life insurance","Parental leave","Retirement plans"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Contract Manufacturing","Engineering Services"],"lifecycle":[{"event":"open","at":"2026-09-02T01:47:54Z"}],"visa":[],"liveness":{"score":64,"band":"ok","label":"Likely open","p_open":1,"p_active":0.849,"p_room":0.75,"age_days":56,"expected_fill_days":69,"reasons":["conf:3","velocity","win:late"],"computed_at":"2026-10-27T05:46:45Z"},"pay":null,"html_url":"https://alion.io/job/nextern-manufacturing-engineer-ii-2nd-shift","json_url":"https://alion.io/job/nextern-manufacturing-engineer-ii-2nd-shift.json","meta":{"generated_at":"2026-10-27T19:30:41Z","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":10110,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-28T00:00:00Z"}},"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":6892},"rest":"https://alion.io/mcp/rest/get_company?id=6892"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fnextern-manufacturing-engineer-ii-2nd-shift"},{"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%2Fnextern-manufacturing-engineer-ii-2nd-shift"},{"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%2Fnextern-manufacturing-engineer-ii-2nd-shift"},{"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/nextern-manufacturing-engineer-ii-2nd-shift\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fnextern-manufacturing-engineer-ii-2nd-shift"}]}