Manufacturing Process Engineer

The Manufacturing Process Engineer is responsible for owning and improving manufacturing processes to ensure safe, compliant, and efficient production of electromechanical medical devices in a regulated manufacturing environment, with a strong sense of ownership and accountability for process performance.

This role requires a hands-on, floor-focused engineer who is actively engaged in product builds, process troubleshooting, equipment performance, and continuous improvement initiatives, working cross-functionally with Production, Quality, and Engineering to drive process capability, resolve technical issues, and support new product introductions (NPI).

The position plays a key role in advancing Lean manufacturing and fostering a One Team culture, delivering practical, data-driven process improvements that enhance quality, efficiency, and reliability.

• Own and optimize manufacturing processes to ensure stability, repeatability, and performance.
• Provide hands‑on support during assembly, testing, and troubleshooting on the production floor to resolve issues in a timely manner.
• Diagnose and resolve process, equipment, and product-related issues in real time.
• Lead and drive continuous improvement initiatives using Lean/DMAIC principles.
• Analyse production data to drive improvements in yield, cycle time, and process efficiency.
• Support root cause investigations, CAPA activities, and process deviations.
• Ensure compliance with ISO 13485, 21 CFR 820, and internal quality systems.
• Participate in process validation activities (IQ/OQ/PQ).
• Support new product introduction (NPI) and technology transfer to manufacturing.
• Develop and maintain SOPs, work instructions, and process documentation.
• Train production and maintenance personnel on processes, equipment, and best practices.
• Collaborate cross‑functionally with Production, Quality, Engineering, and Supply Chain teams.
• Promote a culture of continuous improvement, accountability, and teamwork.

• Technical degree with 0-5 years of experience in a manufacturing environment (medical device preferred), or 5-10 years of equivalent manufacturing experience.
• Strong written and verbal communication skills, including technical documentation.
• Ability to adapt to change and manage multiple priorities effectively.
• Demonstrated problem‑solving skills with the ability to identify issues and take appropriate action.
• Strong organizational skills and ability to meet deadlines and targets.
• Proficiency in Microsoft Office applications.
• Ability to collaborate effectively with cross‑functional teams.
• Ability to work collaboratively with and under the guidance of senior engineers or management.

• Working knowledge of 21 CFR 820 and ISO 13485 regulatory standards.
• Experience with continuous improvement methodologies, including DMAIC, FMEA, structured problem solving, and SPC.
• Hands‑on experience supporting product assembly, testing, and process development within a manufacturing environment.