Position : MDR Project Engineer
Role: MDR Project Engineer
Location: Minneapolis, MN
*Experience Level Required.
Bachelor’s degree with 3 - 5 years’ related experience or Master’s degree with 1 - 3 years’ related experience in Biomedical / Mechanical or equivalent
The Project engineer will be a packaging and labeling coordinator and subject matter expert (SME) to work with the cross-functional team and Customer. This role will interface with the project team and to gather packaging and labeling requirements and update packaging components and labels to comply with new regulations and/or support business needs.
Project engineer will facilitates the Packaging/labeling activities to establish labeling content/ requirement, changes, update for product labels. This role will engage with and mobilize the cross functional team to resolve regulatory gaps effectively, be responsible for coordination between customer SMEs and offshore team and collaborate on continuous improvement initiatives.
Ensure on-time MDR-compliant packaging and labeling submission deliverables complete on time for all relevant product family MDR submissions in scope.
Ensure final MDR-compliant packaging and final translated labeling deliverables are ready on time for NB approval and launch activities to support assigned Business Units and manufacturing sites.Required Skillset:
Excellent people and communication skills (verbal and written)
• Project management experience
• Experience in cross-functional, cross-geography coordination
• Ability to work independently, prioritize and meet deadlines
• Strong collaboration and communication skills, experience working in a matrixed environment
• Exposure to labeling and packaging of Medical devices
• Ability to handle multiple projects on an ongoing basis
• Highly capable of attention to detail and accuracy
• Experience working in a regulated environment
• Knowledge of process excellence, process improvement
• Exceptional verbal and written communication, negotiation and partnering skills
• Demonstrated ability to drive a collaborative, customer-focused, learning culture
• Experience in creating and reviewing documentation, technical documentation, specifications
Experience working in quality systems (e.g., Agile PLM)
Knowledge of European Union Medical Device Regulations
Experience in gap assessments and remediation