{"id":299930,"url":"https://alion.io/job/nextern-engineering-senior-manager","title":"Engineering Senior 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":76,"open_postings":4,"ghost_share":0,"stale_share":0.75,"repost_share":0,"time_to_fill_p50_days":62,"computed_at":"2026-11-12T10:38:37Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Ho Chi Minh City, Vietnam"],"countries":["VN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":12000,"max_usd":27000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":8444},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Mandiant capa","optional":false}],"status":"live","first_seen_at":"2026-07-03T00:00:00Z","employer_posted_date":"2026-07-03","last_verified_at":"2026-11-13T08:02:42Z","board_verified":true,"closed_at":null,"days_open":133,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":133},"description":"POSITION SUMMARY\nThe Engineering Senior Manager provides strategic engineering leadership across four core functional areas: Program Management, Manufacturing Engineering, Process Development, and Operational Excellence. This leader is responsible for building and executing engineering strategies that advance process capability, accelerate new product introduction (NPI), and develop a high-performing technical talent pipeline in a regulated medical device environment.\nThe ideal candidate brings deep hands-on expertise in injection molding, extrusion, and electronics/electromechanical systems, combined with a strong command of quality systems and regulatory requirements applicable to sterile-use medical devices including catheters and fluid delivery systems. This role operates in a fast-paced, globally integrated environment and demands a leader who is equally effective on the manufacturing floor and as well as in leadership forums.\nKEY RESPONSIBILITIES\nProgram Management\nLead and govern cross-functional engineering programs through commercial launch, ensuring on-time, on-budget, and on-quality delivery.\nEstablish and maintain program governance frameworks, milestone reviews, risk registers, and escalation pathways.\nCoordinate engineering resources across internal teams and external development partners, and suppliers.\nPartner with quality and R&D to ensure all programs meet applicable regulatory requirements (FDA 21 CFR Part 820, ISO 13485, MDR, etc.).\nReport program status and engineering KPIs to senior leadership on a regular cadence.\nManufacturing Engineering\nProvide technical oversight and strategic direction for all manufacturing engineering activities supporting electromechanical and single-use sterile medical devices including catheters and fluid delivery systems.\nDrive process validation (IQ/OQ/PQ), equipment qualification, and process control strategies in accordance with design control and GMP requirements.\nLead engineering input into facility layout, capital equipment planning, and manufacturing capacity strategy.\nEnsure manufacturing processes are repeatable, scalable, and compliant with applicable standards.\nOwn technology transfer from development to full-scale manufacturing, including documentation, training, and capability demonstration.\nProcess Development\nDevelop and optimize core manufacturing processes with emphasis on:\nInjection molding (thermoplastics, LSR, insert molding, overmolding)\nExtrusion (catheter tubing, multi-lumen, co-extrusion)\nElectronics assembly and electromechanical integration\nCatheter assembly, tip forming, bonding, and sterile barrier systems\nFluid delivery system assembly and testing\nApply statistical methods (DOE, SPC, Cpk/Ppk analysis, FMEA) to develop robust, capable processes.\nLead process capability development initiatives that systematically reduce variation and improve yield.\nCollaborate with R&D and Product Development to ensure designs are optimized for manufacturability (DFM/DFA).\nMaintain current knowledge of emerging process technologies and drive appropriate adoption.\nOperational Excellence\nChampion a culture of continuous improvement using Lean, Six Sigma, and related methodologies across the engineering organization.\nDefine and track operational metrics (OEE, yield, cycle time, COPQ, scrap rates) and drive performance improvement initiatives.\nLead kaizen events, value stream mapping, and root cause/corrective action (CAPA) efforts.\nPartner with Quality and Operations to build a sustainable quality management system aligned with ISO 13485 and FDA QSR requirements.\nIdentify and eliminate waste across engineering and manufacturing workflows to improve cost and throughput.\nEngineering Strategy & Leadership\nDevelop and execute a multi-year engineering strategy aligned with business objectives, product roadmap, and operational goals.\nBuild and lead a high-performing engineering team; recruit, develop, and retain top technical talent.\nEstablish a technical talent pipeline through structured development programs, mentorship, and succession planning.\nDefine career paths and competency frameworks for engineering roles across the function.\nFoster a culture of engineering excellence, accountability, innovation, and cross-functional collaboration.\nRepresent the engineering function in executive reviews, customer audits, and regulatory inspections.\nManage departmental budgets, headcount planning, and capital expenditure forecasting.\nRequirements\nEducation\nBachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a closely related engineering discipline required.\nMaster's degree (MBA or MS in Engineering or related field) preferred.\nExperience\nMinimum 10+ years of progressive engineering experience in a regulated manufacturing environment, with at least 4 years in an engineering management or senior leadership role.\nDemonstrated expertise in injection molding processes (thermoplastics, LSR, insert molding) required.\nDemonstrated expertise in extrusion processes (catheter tubing, multi-lumen extrusion) required.\nHands-on experience with electronics manufacturing and electromechanical device assembly required.\nProven track record leading NPI programs from development through commercial launch in a regulated environment.\nExperience building engineering capability and talent pipelines in a growth-stage or scaling organization.\nTechnical Skills\nStrong working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and applicable IEC standards.\nProficiency in process validation methodologies (IQ/OQ/PQ) and design control (21 CFR 820.30).\nApplied experience with statistical tools: DOE, SPC, FMEA, GR&R, Cpk/Ppk analysis.\nLean / Six Sigma expertise; Green Belt or Black Belt certification preferred.\nFamiliarity with ERP and MES systems; PLM experience a plus.\nExperience with automated assembly systems and vision inspection integration.\nLeadership & Competencies\nExceptional leadership presence with the ability to influence without authority across functions and geographies.\nStrong strategic thinking with the ability to translate vision into executable engineering roadmaps.\nExcellent communication skills - written and verbal - with the ability to present to executive leadership, customers, and regulatory bodies.\nDemonstrated ability to manage multiple priorities in a fast-paced, deadline-driven environment.\nCollaborative, team-oriented mindset with a bias toward action and accountability.\nAbility and willingness to travel globally as required (estimated up to 30%; higher during ramp-up phases).\nPREFERRED QUALIFICATIONS\nExperience with intravascular or interventional device manufacturing (catheters, guidewires, sheaths, stents, balloon systems).\nExposure to CE Marking, MDR/IVDR, or other international regulatory pathways.\nExperience leading engineering operations across multiple global sites.\nPrior P&L or cost center management responsibility.\nSix Sigma Black Belt or Lean Master certification.\nWORK ENVIRONMENT & PHYSICAL REQUIREMENTS\nWork is performed in a combination of office and cleanroom/manufacturing environments.\nMay be required to wear gowning, PPE, or other cleanroom attire when on the manufacturing floor.\nGlobal travel required, including international travel to manufacturing sites, suppliers, and customer locations.\nAbility to stand, walk, and be present on the production floor for extended periods.\nBenefits\nBenefits Competitive salary\nProfessional and Friendly Working Environment, chance to attend employee's training and development programs\nPremium healthcare Insurance (In Vietnam) & Business travel insurance Health, social & unemployment insurance (following Government regulation)\nCompany trip, New Year party, Team building\nOccasion-based offerings: Birthday, New year, Mid-Autumn","description_format":"text","description_chars":7809,"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":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Contract Manufacturing","Engineering Services"],"lifecycle":[{"event":"open","at":"2026-09-05T15:03:51Z"}],"visa":[],"liveness":{"score":20,"band":"cold","label":"Long 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