Job Description

617633

Our client, a leading Biotechnology company located in Thousand Oaks, CA, is looking for a Medical Device Engineer to 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.

Required Skills:

• Bachelor’s Degree or higher in relevant engineering or scientific field (Mechanical, Biomedical, Bioengineering)
• Understanding of Mechanical Design Engineering Concepts
• Experience with Final Drug Product and/or Drug Product, medical device development, commercialization and knowledge of manufacturing processes (fill-finish)
• Experience with design controls; including (but not limited to) design verification and transfer
• Understanding of risk assessments including hazard and probability analysis
• Experience with investigations and quality records
• Laboratory and electronic lab notebook experience
• Statistical Analysis software (Minitab or JMP)

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

***Compensation within this range will be commensurate with level of experience***

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