Engineer, Medical Devices (JP12013)
About The Position
The Device Engineer will participate in the design, development, and lifecycle management design control activities for commercialized drug delivery devices. This role includes technical operations support for combination product development to global launch, clinical and commercial manufacturing, failure investigation, design change evaluation, development and execution of test procedures, and continuous improvement initiatives. Scope includes mechanical delivery devices, such as Prefilled syringes. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of these mechanical delivery devices are maintained. The engineer will participate in cross functional teams, leading device design activities such as the development of product enhancements, analytical failure analysis and implementation of design solutions, assessment of proposed changes, support product launches, and defend inspection and ensure the follow through of commitments.
Requirements
- Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience
- Hands on Laboratory Experience in a GLP Setting (Science or Engineering Lab)
- Good Communication and Technical Writing Skills
- Ability to Multitask
Nice To Haves
- Fill-Finish experience
Responsibilities
- Participate in the design, development, and lifecycle management design control activities for commercialized drug delivery devices.
- Provide technical operations support for combination product development to global launch, clinical and commercial manufacturing, failure investigation, design change evaluation, development and execution of test procedures, and continuous improvement initiatives.
- Maintain design history files of mechanical delivery devices.
- Participate in cross functional teams, leading device design activities such as the development of product enhancements, analytical failure analysis and implementation of design solutions, assessment of proposed changes, support product launches, and defend inspection and ensure the follow through of commitments.
- Author protocols, reports, and further technical documentation while adhering to GMP standards.
- Perform laboratory testing using an Instron force tester and vision systems.
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What This Job Offers
Career Level
Mid Level
