We are looking for a Staff Engineer LCM for our Medical Device client in Leiden, NL! This is a critical position whereby you will be responsible for site products and components life cycle management and new product introduction.
Responsibilities
Manages and executes projects and/or programs of high-level complexity ensuring safety, regulatory compliance, company standards, operation requirements and business needs are met.
Responsible for providing technical support and be coordinator between component sourcing and suppliers for activities of new material cut in and old material phase out.
Lead labeling design projects, work closely with global and local teams to make sure the labels meet regulatory and marketing requirements.
Work with design team to confirm manufacturing bill of material, coordinate BOM Drawing, and cooperate with local engineering team on BOM change and management.
Leading collaborative team meetings with cross-functional subject matter experts (SME) to arrive at consensus for labeling content changes. Under very limited to no supervision and at times independently coordinates lifecycle product labeling content input collection.
Represent the Labeling COE to customer groups, and functional business partners, while responding to and/or escalating as appropriate within the labeling COE to meet the needs and respond to requests escalations and inquiries from the business, as needed.
Responsible for Unique Device Identification (UDI) application and management, make sure all product UDI complies with local regulatory requirement.
Overall management of design change projects. Work closely with local and global teams to track projects progress.
Organize review meetings to identify the process and risks. including risk mitigation.
Follows Standard Operating Procedures (SOP), Good Manufacturing Practices (GMPs), Company Policies and Federal, State and Local Government Regulations.
Writes, develops and implements validation procedures.
Requirements
Bachelor’s or master’s degree in an engineering discipline.
A minimum of 6-8 years’ work experience in engineering and/or package labeling in a medical device environment preferred.
Must have fluent and excellent English reading, listening, writing, and speaking.
Experience in collaboration within a team environment across multiple time zones.
Practicalities
Location: Leiden, Netherlands
Duration: 1 year contract with the possibility of extension
Stat-date: ASAP
Hybrid position
Full-time
Sound interesting?
Send your CV to Khanyi Mabena at k.mabena@panda-int.com or contact her on +31 2020 44502.