Engineering Senior Manager
Nextern
Engineering Senior Manager
Nextern
Designs and manufactures medical devices
Nextern · Ho Chi Minh City, Vietnam · Full-time · Posted 2026-07-03
Workplace: on_site
Department: Engineering
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:
• 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.
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.
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Nextern designs and manufactures medical devices for equipment makers, with engineering and factory teams involved from early prototypes through production. Its work includes catheter-based instruments and electronic systems used in minimally invasive treatment and diagnostic procedures. Customers pay for development and contract manufacturing services, with project costs shaped by device complexity, materials and production scale. Its clinical markets include vascular and heart interventions and nerve stimulation, with services sold separately or as an integrated program. Founded in 2000 with industrial engineering roots, Nextern shifted to medical devices in 2016 and is headquartered in Maple Grove, Minnesota.
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