Design Assurance & Process Development Manager at Arjo improving product creation processes for healthcare. Leading cross-functional teams and ensuring regulatory compliance in medical device engineering.
Responsibilities
Act as the driver of the Arjo Product Creation Process, and as the owner of the Design Assurance & Systems Engineering sub-process, ensuring they are robust, compliant, and continuously improved.
Coordinate the Design Assurance function across PD&E, ensuring teams alignment and securing capabilities.
Develop, standardize, document and maintain various PD&E processes and procedures (SOP).
Collaborate with cross-functional teams and lead improvement projects across PD&E, aiming to harmonize workflows, roles & responsibilities and implement best practices.
Drive communication, build training & support materials and execute training sessions for stakeholders.
Requirements
Bachelor’s degree in Engineering, Technology, or a relevant technical field.
Excellent knowledge of Product Development and Engineering processes, as well as regulatory and quality requirements applicable to Medical Devices.
Minimum 7 years of experience in PD&E or related functions, including expert/SME experience.
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