Engineering Senior Manager

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

• Benefits Competitive salary
• Professional and Friendly Working Environment, chance to attend employee's training and development programs
• Premium healthcare Insurance (In Vietnam) \& Business travel insurance Health, social \& unemployment insurance (following Government regulation)
• Company trip, New Year party, Team building
• Occasion-based offerings: Birthday, New year, Mid-Autumn