# Engineering Senior Manager > Nextern · Ho Chi Minh City, Vietnam · Full-time · Posted 2026-07-03 **Workplace:** on_site **Department:** Engineering ## Description **POSITION SUMMARY** The 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. The 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. **KEY RESPONSIBILITIES** **Program Management** •       Lead and govern cross-functional engineering programs through commercial launch, ensuring on-time, on-budget, and on-quality delivery. •       Establish and maintain program governance frameworks, milestone reviews, risk registers, and escalation pathways. •       Coordinate engineering resources across internal teams and external development partners, and suppliers. •       Partner with quality and R&D to ensure all programs meet applicable regulatory requirements (FDA 21 CFR Part 820, ISO 13485, MDR, etc.). •       Report program status and engineering KPIs to senior leadership on a regular cadence. **Manufacturing Engineering** •       Provide technical oversight and strategic direction for all manufacturing engineering activities supporting electromechanical and single-use sterile medical devices including catheters and fluid delivery systems. •       Drive process validation (IQ/OQ/PQ), equipment qualification, and process control strategies in accordance with design control and GMP requirements. •       Lead engineering input into facility layout, capital equipment planning, and manufacturing capacity strategy. •       Ensure manufacturing processes are repeatable, scalable, and compliant with applicable standards. •       Own technology transfer from development to full-scale manufacturing, including documentation, training, and capability demonstration. **Process Development** •       Develop and optimize core manufacturing processes with emphasis on: - Injection molding (thermoplastics, LSR, insert molding, overmolding) - Extrusion (catheter tubing, multi-lumen, co-extrusion) - Electronics assembly and electromechanical integration - Catheter assembly, tip forming, bonding, and sterile barrier systems - Fluid delivery system assembly and testing •       Apply statistical methods (DOE, SPC, Cpk/Ppk analysis, FMEA) to develop robust, capable processes. •       Lead process capability development initiatives that systematically reduce variation and improve yield. •       Collaborate with R&D and Product Development to ensure designs are optimized for manufacturability (DFM/DFA). •       Maintain current knowledge of emerging process technologies and drive appropriate adoption. **Operational Excellence** •       Champion a culture of continuous improvement using Lean, Six Sigma, and related methodologies across the engineering organization. •       Define and track operational metrics (OEE, yield, cycle time, COPQ, scrap rates) and drive performance improvement initiatives. •       Lead kaizen events, value stream mapping, and root cause/corrective action (CAPA) efforts. •       Partner with Quality and Operations to build a sustainable quality management system aligned with ISO 13485 and FDA QSR requirements. •       Identify and eliminate waste across engineering and manufacturing workflows to improve cost and throughput. **Engineering Strategy & Leadership** •       Develop and execute a multi-year engineering strategy aligned with business objectives, product roadmap, and operational goals. •       Build and lead a high-performing engineering team; recruit, develop, and retain top technical talent. •       Establish a technical talent pipeline through structured development programs, mentorship, and succession planning. •       Define career paths and competency frameworks for engineering roles across the function. •       Foster a culture of engineering excellence, accountability, innovation, and cross-functional collaboration. •       Represent the engineering function in executive reviews, customer audits, and regulatory inspections. •       Manage departmental budgets, headcount planning, and capital expenditure forecasting. ## Requirements **Education** •       Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a closely related engineering discipline required. •       Master's degree (MBA or MS in Engineering or related field) preferred. **Experience** •       Minimum 10+ years of progressive engineering experience in a regulated manufacturing environment, with at least 4 years in an engineering management or senior leadership role. •       Demonstrated expertise in injection molding processes (thermoplastics, LSR, insert molding) required. •       Demonstrated expertise in extrusion processes (catheter tubing, multi-lumen extrusion) required. •       Hands-on experience with electronics manufacturing and electromechanical device assembly required. •       Proven track record leading NPI programs from development through commercial launch in a regulated environment. •       Experience building engineering capability and talent pipelines in a growth-stage or scaling organization. **Technical Skills** •       Strong working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and applicable IEC standards. •       Proficiency in process validation methodologies (IQ/OQ/PQ) and design control (21 CFR 820.30). •       Applied experience with statistical tools: DOE, SPC, FMEA, GR&R, Cpk/Ppk analysis. •       Lean / Six Sigma expertise; Green Belt or Black Belt certification preferred. •       Familiarity with ERP and MES systems; PLM experience a plus. •       Experience with automated assembly systems and vision inspection integration. **Leadership & Competencies** •       Exceptional leadership presence with the ability to influence without authority across functions and geographies. •       Strong strategic thinking with the ability to translate vision into executable engineering roadmaps. •       Excellent communication skills — written and verbal — with the ability to present to executive leadership, customers, and regulatory bodies. •       Demonstrated ability to manage multiple priorities in a fast-paced, deadline-driven environment. •       Collaborative, team-oriented mindset with a bias toward action and accountability. •       Ability and willingness to travel globally as required (estimated up to 30%; higher during ramp-up phases). **PREFERRED QUALIFICATIONS** •       Experience with intravascular or interventional device manufacturing (catheters, guidewires, sheaths, stents, balloon systems). •       Exposure to CE Marking, MDR/IVDR, or other international regulatory pathways. •       Experience leading engineering operations across multiple global sites. •       Prior P&L or cost center management responsibility. •       Six Sigma Black Belt or Lean Master certification. **WORK ENVIRONMENT & PHYSICAL REQUIREMENTS** •       Work is performed in a combination of office and cleanroom/manufacturing environments. •       May be required to wear gowning, PPE, or other cleanroom attire when on the manufacturing floor. •       Global travel required, including international travel to manufacturing sites, suppliers, and customer locations. •       Ability to stand, walk, and be present on the production floor for extended periods. ## Benefits 1. Benefits Competitive salary 2. Professional and Friendly Working Environment, chance to attend employee's training and development programs 3. Premium healthcare Insurance (In Vietnam) & Business travel insurance Health, social & unemployment insurance (following Government regulation) 4. Company trip, New Year party, Team building 5. Occasion-based offerings: Birthday, New year, Mid-Autumn ## Apply [Apply at Nextern](https://apply.workable.com/nextern/j/8A8C127996/apply) --- Powered by [Workable](https://www.workable.com)