Engineer

Payrate : $ - $

Summary :

The Device Engineer will participate in the design, development, and lifecycle management of 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, defend inspection and ensure the follow through of commitments.

Responsibilities :

• Adheres to strict documentation practices in a GMP regulated environment
• Engineering competency in all conventional aspects of the subject matter, functional area, and assignments
• Plans and performs work, independently evaluating, selecting, and adapting standard methods, and creating new solutions to engineering problems.
• Authors and reviews technical documentation including protocols, reports, and technical assessments
• Coordinates and executes laboratory testing to support characterization, verification, design transfer, and fill-finish efforts
• Analyze and trend generated data by applying relevant statistical techniques to enable senior staff to make informed decisions
• Maintains device and combination product design history files for assigned products
• Ensure test methods and test protocols are developed in a sound and robust framework with high focus on eliminating test errors
• Provides functional subject matter expertise to actively participate in cross-functional activities including system level root cause analysis, design changes, and change control assessments
• Provide general laboratory support including inventory management, sample shipments, and cleanup.
• Works with Scientists and Engineers, to assess and develop appropriate design and manufacturing specifications

Preferred Qualifications :

Top Must Have Skill Sets :

Pay Transparency : The typical base pay for this role across the is : $ - $ Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, paid days off, (k) plan participation, commuter benefits and life and disability insurance.

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