As a Project Engineer within Site Technical Services (STS) MDCP, you provide technical, scientific and project-driven support to ensure robust pharmaceutical manufacturing. You lead and/or support technical improvements, problem solving and the execution of implementation projects, fully aligned with GMP and internal quality systems. As a Technical Leader you are responsible for sustaining on-market Medical Device and Combination Products (MDCP) through product/process change and risk management activities. Production site and R&D facing role. Primary responsibilities include facilitating product launch, leading post-market changes, and identifying opportunities for continuous improvement.Key ResponsibilitiesSupport investigations of delivery system customer complaints to determine root cause and implement appropriate corrective preventive actionsSupport Manufacturing Quality Assurance in the disposition of Non-Conforming Reports, qualification of material / processes / changes to assure reliability requirements are metLead or support project management activities including scoping, planning, risk assessments and execution of improvement or investment projectsDrive process and system improvements (lean/continuous improvement) with a focus on Design History File (DHF) enhancements / updates for specific device presentation / platformPrepare, execute and document changes with a focus on design changes, process changes and risk management updates; perform impact assessments and required (re)qualificationPlan and execute technical strategy, protocols, tests and reports for line extensions and market expansion activities with production sites and Regulatory AffairsDevelop and maintain technical documentation (protocols, reports, work instructions, risk analyses)Coordinate with Operations, QA, Engineering and suppliers; ensure clear communication and on‑time deliveryLiaison between GT&E Device Engineering Lifecycle Management (DELCM) and internal production sites, Regulatory, and Quality colleaguesIdentify, communicate, develop mitigation strategies for technical risks with key stakeholders per appropriate escalation thresholdPromote and comply with EHS guidelines; integrate safety requirements in designs and changesProfile:Master degree (Industrial/Engineering) or equivalent through experienceRelevant experience in pharmaceutical or medical device manufacturing, technical support or project engineering is a plusKnowledge of GMP and technical standardsStrong analytical and problem‑solving skills; decisive and structuredStrong communicator; able to collaborate effectively across functionsProject management capabilities including planning, prioritization, risk control and stakeholder engagementDetail‑oriented, quality‑focused and safety‑conscious; proactive and accountableMasters or higher degree in Mechanical, Biomedical, Chemical or Manufacturing Engineering or related science is requiredNice to have:Strong knowledge of 21 CFR Part 820, ISO 13485 and ISO 14971 and related standards (design controls and device risk management)Experience with medical devices and/or combination product technologyExperience with injection molding technologies pertaining the medical device and/or combination product industry.