Senior Engineering Manager (Electronic, Injection molding )

Location: Binh Duong

Job Description

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.

Required working 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.

Required qualifications

·       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.

Required Languages:

·      Fluent in English

Required knowledge and skills

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.