Manufacturing Engineer

About the RoleWe are seeking a skilled Manufacturing Engineer to join our growing team and support the production of innovative, life-changing medical devices. In this role, you will drive process improvements, ensure compliance with regulatory standards and collaborate closely with cross-functional teams to deliver high-quality products to patients worldwide.Key ResponsibilitiesDevelop, optimize and validate manufacturing processes for medical device production, ensuring efficiency, safety, and quality.Lead continuous improvement initiatives using Lean, Six Sigmaand root-cause analysis methodologies.Support equipment selection, installation, qualification (IQ/OQ/PQ) and ongoing maintenance.Create and maintain manufacturing documentation including work instructions, process flow diagrams, PFMEAs and control plans.Partner with R&D on new product introduction (NPI) to ensure robust design-for-manufacturability (DFM) and smooth scaling to production.Monitor key performance indicators (KPIs) and implement corrective/preventive actions (CAPA) as needed.Ensure all manufacturing activities comply with relevant regulatory and quality standards (e.g., ISO 13485, FDA 21 CFR Part 820).Train operators and technicians on new processes and equipment.QualificationsBachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or related field.3+ years of experience in manufacturing engineering, preferably within the medical device or regulated industry.Strong understanding of Lean Manufacturing, Six Sigma tools, and statistical analysis.Experience with process validation, equipment qualification, and documentation in a regulated environment.Working knowledge of CAD software (SolidWorks, Creo, or similar).Excellent problem-solving, communication, and cross-functional collaboration skills.Preferred SkillsSix Sigma Green Belt or Black Belt certification.Experience with automation, robotics, or high-volume manufacturing.Familiarity with risk management tools (FMEA, fault tree analysis).Knowledge of polymer processing, machining, or assembly techniques relevant to medical devices.For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose.