Project Engineer - Medical Device & Combination Products (MDCP)
Antwerp
Life Sciences - Validation and Qualification
Master
Work experience: 5-7
Reference number: 93603
Our client, a leading pharmaceutical and medical device organization, is seeking a Project Engineer to provide technical, scientific, and project-driven support for manufacturing operations. The role focuses on leading technical improvements and sustaining on-market products through product change management and risk assessment activities.
Your responsibilities:
- Lead project management activities including scoping, planning, and execution of technical improvement or investment projects.
- Support root cause investigations for delivery system customer complaints and implement appropriate corrective and preventive actions.
- Drive process and system improvements with a focus on enhancing and updating Design History Files.
- Prepare and execute design and process changes, including impact assessments and required requalification.
- Develop technical documentation such as protocols, reports, work instructions, and risk analyses.
- Coordinate with operations, quality assurance, and suppliers to ensure clear communication and on-time project delivery.
What are we looking for?
- You have a Master’s degree or higher in Mechanical, Biomedical, Chemical, or Manufacturing Engineering.
- You bring 3+ years of relevant experience in pharmaceutical or medical device manufacturing, technical support, or project engineering.
- You possess strong knowledge of GMP and technical standards within a regulated manufacturing environment.
- You have proven project management capabilities including planning, prioritization, risk control, and stakeholder engagement.
- You are analytical, detail-oriented, and able to collaborate effectively across different functions.
- You are fluent in English with knowledge of Dutch considered a plus.
Nice to Haves
- Strong knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971 regarding design controls and device risk management.
- Experience with injection molding technologies pertaining to the medical device or combination product industry.
- Direct experience with medical device or combination product technology.
What do we offer?
- Enjoy a competitive salary package with extra perks that recognize your talent.
- Advance your career with a clear growth path, coaching, and mentoring to support you.
- Thrive in a dynamic and supportive environment where you can truly make an impact.
- Work when and where you perform best, ensuring an optimal work-life balance.
- Choose a flexible transport solution, from a company car to a public transport subscription.
- Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
- Grow your skills with external courses and our in-house Pauwels Academy.
- Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
- Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.
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