Γραφείο Διασύνδεσης & Σταδιοδρομίας - Sr Engineer

Description

Amgen Job Description Device Engineering is responsible for developing and managing life cycle of drug delivery devices. This group is responsible for managing post launch activities as part of life cycle management. Position will own and be responsible for maintaining multi product design history file as well as support development next generation devices and pipeline device launches.

Participate in the design transfer and lifecycle management related activities for commercial drug delivery devices. This includes technical operations support for contract manufacturing, failure investigation, leading and assessing design changes, develop test procedures, scale-up and global launch, supplier development, and continues improvement.

Scope includes mechanical and electro-mechanical delivery devices, such as; fluid transfer devices, automatic pen injectors, and micro-infuser delivery pump systems. Be part of a sustaining engineering team that ensures successful device design transfer of these mechanical and electro-mechanical delivery devices. Focus on design/development engineering assignments focused on commercial mechanical, electro-mechanical systems, and fluid-mechanical systems.

Essential skills and Responsibilities:

• Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments, plans and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures and criteria and devises new approaches to problems encountered.

• Accountability of maintaining technical records within design history file associated with assigned products

• Develop Test Method, generate and maintain design specification, protocol & report writing, prototyping, DOE/SPC product optimization, design verification & validation, FMEA, etc.

• Lead system level root cause investigation, coordinate design improvements with development partners, strategic planning and execution of design changes and improvements.

• Works with Scientists and Engineers internally and externally to assess and develop appropriate design and manufacturing specifications

• Individual contributor with Leadership attributes to effectively represent device engineer within a large network/matrix organization

• 10% domestic and international travel
Basic Qualifications • Doctorate degree OR Master's degree & 3 years of Engineering and/or device development/manufacturing experience

OR

• Bachelor's degree & 5 years of Engineering and/or device development/manufacturing experience

OR

• Associate's degree & 10 years of Engineering and/or device development/manufacturing experience

OR

• High school diploma / GED & 12 years of Engineering and/or device development/manufacturing experience
Preferred Qualifications • Bachelor's degree in enginee...