Engineer

Fully onsite at Thousand Oaks, CA

Standard business hours 8:00 - 5:00 PM

Job Details: 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.

Essential Skills and 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:

• 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)
• Experience with Instron force testers using BlueHill Universal
• Test method development, GR&R, and text fixture design
• Ability to work independently and dynamically across functional teams
• Strong technical writing and verbal communication skills including technical presentations (i.e., PowerPoint)
• Ability to support complex workstreams under demanding timeline
• Understanding of the following standards and regulations: Quality System Regulation – 21CFR820; Quality Management System for medical device/component manufacturers - ISO 13485 Risk Management for Medical Devices – ISO 14971; EU Medical Device Regulation – 2017/745