{"id":198405,"url":"https://alion.io/job/nextern-manufacturing-engineering-manager","title":"Manufacturing Engineering Manager","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":"2026-10-25T05:49:26Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"lead","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":95000,"max_usd":192000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":1829},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"SolidWorks","optional":false}],"status":"live","first_seen_at":"2026-09-03T00:00:00Z","employer_posted_date":"2026-09-03","last_verified_at":"2026-10-25T23:37:10Z","board_verified":true,"closed_at":null,"days_open":53,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":53},"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 Engineering Manager leads the manufacturing engineering team supporting new product introduction and transfer, process development and validation, automation, and sustaining engineering at Nextern’s US medical device CDMO site, delivering capable, compliant, and cost-effective manufacturing processes in support of commercial production at the Maple Grove facility.\nResponsibilities:\nDirectly supervises manufacturing engineering staff, including manufacturing and process engineers, automation engineers, and engineering technicians. Responsibilities include hiring, training, scheduling, performance management, and development in accordance with company policies and applicable laws.\nLead daily manufacturing engineering activities, including process development, equipment and tooling support, automation, and sustaining engineering for commercial production lines.\nSupervise, train, and develop manufacturing and process engineers and engineering technicians; set objectives and manage performance.\nEstablish and track KPIs (first pass yield, scrap and rework, OEE, cycle time, on-time completion of engineering deliverables) and drive corrective actions.\nPartner with operations, quality, program management, and customers to support commercial production schedules and product transfer milestones.\nLead transfer of customer designs into commercial production, including process development, tooling and fixturing, line layout, and capacity planning.\nOwn process characterization and validation (IQ/OQ/PQ), test method validation, and pFMEA and control plan development.\nProvide design for manufacturability (DFM) feedback to customers and internal design teams during development.\nSpecify, qualify, and maintain manufacturing equipment, automation, tooling, and fixtures; manage capital projects from justification through installation and qualification.\nDrive process capability improvements using statistical methods (SPC, Cp/Ppk, DOE) to reduce variation, scrap, and rework.\nProvide technical troubleshooting for production issues, nonconformances, and CAPA investigations; implement effective root cause corrective actions.\nEnsure processes, validations, and records comply with 21 CFR Part 820, ISO 13485, GDP, and site EHS/safety policies; support internal, customer, and regulatory audits.\nApply lean, 5S, and Six Sigma principles to improve manufacturing flow, reduce cost, and increase throughput and capacity.\nRequirements\nRequired:\nBachelor's degree in a STEM related field\n8+ years of progressive manufacturing or process engineering experience, including 2+ years in a leadership role; medical device or regulated manufacturing strongly preferred.\nDemonstrated experience transferring new products into commercial production, including process development, process validation (IQ/OQ/PQ), and test method validation.\nHands-on experience with automation, tooling and fixture design, and equipment qualification; CAD proficiency (SolidWorks or equivalent).\nCertifications preferred: Six Sigma Green Belt or Black Belt, Lean, or PMP.\nWorking knowledge of 21 CFR Part 820, ISO 13485, and Good Documentation Practices; experience with design controls, risk management (ISO 14971), pFMEA, and CAPA.\nStrong statistical, problem-solving, and communication skills; proficiency with Minitab or equivalent and data-driven decision making.\nSalary Range:\n$130,000 tp $160,000 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":4554,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":2,"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":["Industrial Engineering","Contract Manufacturing","Engineering Services"],"lifecycle":[{"event":"open","at":"2026-09-03T21:18:25Z"}],"visa":[],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.844,"p_room":0.75,"age_days":52,"expected_fill_days":69,"reasons":["conf:1","velocity","win:late"],"computed_at":"2026-10-25T05:49:26Z"},"pay":null,"html_url":"https://alion.io/job/nextern-manufacturing-engineering-manager","json_url":"https://alion.io/job/nextern-manufacturing-engineering-manager.json","meta":{"generated_at":"2026-10-26T00:09:53Z","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":120,"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":6892},"rest":"https://alion.io/mcp/rest/get_company?id=6892"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fnextern-manufacturing-engineering-manager"},{"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-engineering-manager"},{"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-engineering-manager"},{"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-engineering-manager\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fnextern-manufacturing-engineering-manager"}]}