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 Responsibilities
* Support investigations of delivery system customer complaints to determine root cause and implement appropriate corrective preventive actions
* Support Manufacturing Quality Assurance in the disposition of Non-Conforming Reports, qualification of material / processes / changes to assure reliability requirements are met
* Lead or support project management activities including scoping, planning, risk assessments and execution of improvement or investment projects
* Drive process and system improvements (lean/continuous improvement) with a focus on Design History File (DHF) enhancements / updates for specific device presentation / platform
* Prepare, execute and document changes with a focus on design changes, process changes and risk management updates; perform impact assessments and required (re)qualification
* Plan and execute technical strategy, protocols, tests and reports for line extensions and market expansion activities with production sites and Regulatory Affairs
* Develop and maintain technical documentation (protocols, reports, work instructions, risk analyses)
* Coordinate with Operations, QA, Engineering and suppliers; ensure clear communication and on‐time delivery
* Liaison between GT&E Device Engineering Lifecycle Management (DELCM) and internal production sites, Regulatory, and Quality colleagues
* Identify, communicate, develop mitigation strategies for technical risks with key stakeholders per appropriate escalation threshold
* Promote and comply with EHS guidelines; integrate safety requirements in designs and changes
Profile:
* Master degree (Industrial/Engineering) or equivalent through experience
* Relevant experience in pharmaceutical or medical device manufacturing, technical support or project engineering is a plus
* Knowledge of GMP and technical standards
* Strong analytical and problem‐solving skills; decisive and structured
* Strong communicator; able to collaborate effectively across functions
* Project management capabilities including planning, prioritization, risk control and stakeholder engagement
* Detail‐oriented, quality‐focused and safety‐conscious; proactive and accountable
* Masters or higher degree in Mechanical, Biomedical, Chemical or Manufacturing Engineering or related science is required
Nice 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 technology
* Experience with injection molding technologies pertaining the medical device and/or combination product industry.