Lead manufacturing performance, automation projects, and quality compliance within a regulated medical device environment. Act as the senior technical lead responsible for introducing new equipment, improving manufacturing processes, ensuring regulatory compliance, and supporting cross‑functional business objectives.
Key Responsibilities
Lead the introduction of automated manufacturing equipment and production lines, managing the full lifecycle from design and commissioning through validation and production ramp‑up.
Deliver capital and process improvement projects safely, on time, and in compliance with quality and regulatory requirements.
Monitor and improve manufacturing performance, including output, yield, cycle time, downtime, and overall equipment effectiveness.
Apply structured problem‑solving and continuous improvement methodologies to resolve technical issues and optimise processes.
Ensure compliance with GMP, FDA, ISO, and internal quality standards.
Lead and support validation activities (IQ/OQ/PQ) and maintain associated risk management and quality documentation, including FMEA and critical quality attributes.
Collaborate with Operations, Quality, Regulatory Affairs, R&D, suppliers, and external manufacturing partners.
Serve as the primary technical interface between engineering, quality, and manufacturing teams.
Experience & Skills
5+ years' experience in manufacturing, process, automation, or project engineering.
Experience delivering automation or capital equipment projects within a regulated industry such as medical devices or pharmaceuticals.
Strong knowledge of manufacturing systems, automation technologies, vision systems, process validation, and statistical analysis.
Proven ability to lead projects, solve complex technical problems, influence stakeholders, and deliver measurable business improvements.
Excellent communication, leadership, and cross‑functional collaboration skills.
#J-18808-Ljbffr