Career Category

Job Description

The device engineer will participate in the design, development and lifecycle management related activities for commercial drug delivery devices. This includes technical operations support for design control activities, contract manufacturing, failure investigation, leading and assessing design changes, development test procedures, scale-up and global launch, supplier development, and continuous improvement.

Drug delivery devices for this role include prefilled syringes and lyophilization kits. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of the mechanical delivery devices are maintained. The engineer will participate in cross functional teams, leading device design activities such as developing product enhancements, analytical failure analysis and implementing design solutions, assessment of proposed changes, product launches, and defending inspection and follow through of commitments.

Essential skills and Responsibilities:

• The Device Engineer will be responsible for applying all conventional aspects of the subject matter, functional area, and assignments. This individual will plan, and conduct work requiring judgment in the independent evaluation, selection, and adaptation and modification of standard techniques, procedures and criteria and devise new approaches to problems encountered.
• Accountability of developing and 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 or supports system level root cause investigation, coordinate design improvements with development partners 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 engineering within a large network/matrix organization.

This position will be located in Thousand Oaks, CA and with up to 10% domestic and international travel.

Basic Qualifications:

• Master’s Degree OR
• Bachelor’s Degree and 2 years of Engineering and/or Operations experience OR
• Associate’s degree and 6 years of Engineering and/or Operations experience OR
• High school diploma/GED and 8 years of Engineering and/or Operations experience

Preferred Qualifications:

• Medical device industry experience and regulated work environment experience
• A background in development and commercialization of medical devices and knowledge of manufacturing processes
• Strong understanding and experience in design controls, failure investigation, initiating and bringing complex projects to conclusion
• Familiar with the following standards and regulations: Quality System Regulation – 21CFR820, Risk Management – ISO 14971, EU Medical Device requirements – Council Directive 93/42/EEC
• Ability to work independently and across functional teams
• Excellent (technical) written and verbal communication