{"id":1642819,"url":"https://alion.io/job/nextern-principal-manufacturing-engineer","title":"Principal Manufacturing Engineer","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":"A","score":85,"open_postings":5,"ghost_share":0,"stale_share":0.4,"repost_share":0,"time_to_fill_p50_days":69,"computed_at":"2026-10-06T05:45:30Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"lead","employment_type":"full_time","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":{"min":130000,"max":165000,"currency":"USD","period":"year","gross":null,"usd_annual":165000},"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"AutoCAD","optional":false},{"name":"CAPA","optional":false},{"name":"SolidWorks","optional":false}],"status":"live","first_seen_at":"2026-10-01T22:36:22Z","employer_posted_date":"2026-10-01","last_verified_at":"2026-10-06T19:46:00Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"NPX Medical is a division of Nextern - a global, vertically integrated medical device development and manufacturing platform. We specialize in precision metal components and assemblies, with deep expertise in nitinol engineered components, precision laser cutting and processing, and advanced catheter technologies. Our engineers bring decades of combined experience - from R&D and rapid prototyping through full commercial production.\nWe are seeking an experienced Manufacturing Engineer with a strong background in medical device production to join our dynamic manufacturing team. This role requires a versatile professional who can manage multiple complex projects while ensuring compliance with stringent medical device industry standards and regulations. The ideal candidate will have 5+ years of experience in medical device manufacturing, demonstrating improved: manufacturing methods, systems and processes to produce a high-quality product.\nRESPONSIBILITIES:\nProcess Development Lead manufacturing process development and validation activities: engineering protocols, IQ, OQ, PQ reports, bill of materials, assembling instructions, manufacturing instructions and procedures.\nProcess Support & Optimization: Troubleshoot & Optimize manufacturing processes for medical devices ensuring efficient production while maintaining quality standards.\nTechnical Documentation: Write, review, and maintain manufacturing procedures, work instructions, Standard Operating Procedures (SOPs), and process specifications in compliance with FDA regulations and ISO 13485 standards.\nFixture & Tooling Design: Design, develop, and implement manufacturing fixtures, tooling, and equipment for production of medical devices, ensuring proper functionality and compliance with design controls.\nProblem Solving & Continuous Improvement: Lead root cause analysis investigations, implement corrective and preventive actions (CAPA), and drive continuous improvement initiatives to enhance product quality, reduce waste, and improve manufacturing efficiency.\nCross-Functional Collaboration: Work closely with Quality Assurance, R&D, and Production teams to ensure seamless product launches.\nRequirements\nRequired:\nBachelor’s degree in Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, or related technical field.\n10+ years of experience in medical device manufacturing engineering\nProficiency in CAD software (SolidWorks, AutoCAD, or similar)\nKnowledge of statistical process control (SPC) and lean manufacturing; understanding of medical device validation processes (Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)).\nThorough understanding of ISO 13485:2016 Medical Device Quality Management System.\nMetal based components, assemblies, and processing\nSalary range: $130,000 to 165,000 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":3582,"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":[]},"benefits":["Life insurance","Parental leave","Retirement plans"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Manufacturing","Professional Services"],"lifecycle":[{"event":"open","at":"2026-10-01T22:36:22Z"}],"visa":[],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":4,"expected_fill_days":69,"reasons":["conf:1","velocity","win:early"],"computed_at":"2026-10-06T05:45:30Z"},"pay":{"stated_usd_annual":165000,"is_top_pay":false},"html_url":"https://alion.io/job/nextern-principal-manufacturing-engineer","json_url":"https://alion.io/job/nextern-principal-manufacturing-engineer.json","meta":{"generated_at":"2026-10-06T22:20:44Z","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","counted_by":"address","units_charged":1,"used_today":2670,"day_limit":5000,"remaining_today":2330,"minute_limit":60,"resets_at":"2026-10-07T00:00:00Z"}},"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-principal-manufacturing-engineer"},{"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-principal-manufacturing-engineer"},{"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-principal-manufacturing-engineer"},{"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-principal-manufacturing-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fnextern-principal-manufacturing-engineer"}]}