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.
* 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.