Project Engineer Medical Devices
Antwerpen – contracting
Your responsibilities?
- Provide technical, scientific and project-driven support to ensure robust pharmaceutical manufacturing within Site Technical Services (STS) MDCP.
- Lead and/or support technical improvements, problem solving and the execution of implementation projects, fully aligned with GMP and internal quality systems.
- Sustain on-market Medical Device and Combination Products (MDCP) through product/process change and risk management activities as Technical Leader.
- Act as production site and R&D facing role.
- Facilitate product launch.
- Lead post-market changes.
- Identify opportunities for continuous improvement.
- 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.
- 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.
- 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.
Your profile?
- Engineering degree (Bio-engineering or Industrial Engineering preferred)
- Project Engineer with experience
- Able to work independently from the start
- Autonomous and practical mindset
- Strong project engineering fundamentals
- GMP knowledge is a plus
Strong plus (not mandatory):
- Design control
- Medical device regulations
- Product design in MedTech
- Injection techniques related to MedTech
- Risk assessment and control strategy in MedTech
Our offer?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply.