The CPE Device Engineer is essential part of our team in the design development and lifecycle management related activities for commercialized drug delivery devices. This includes technical operations support for contract manufacturing, failure investigation, leading and assessing design changes, developing test procedures, scale-up and global launch, supplier development, and continuous improvement.
The life changing products that this position will be contributing to include mechanical and electro-mechanical delivery devices, such as fluid transfer devices, automatic pen injectors, reusable automatic injectors, or micro-infuser delivery pump systems. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of these mechanical and electro-mechanical delivery devices are maintained. The Engineer will participate in multi-functional teams, leading device design activities such as developing product improvements, supporting new development project teams, analytical failure analysis and implementing design solutions, assessment of proposed changes, product launches, and defending inspection and follow through of commitments.
- Develop test methods, generate and maintain design specifications, protocol & report writing, prototyping, DOE/SPC product optimization, design verification & validation, FMEA, etc.
- Accountability of maintaining technical records within design history file associated with assigned products
- The Device Engineer is responsible to apply all conventional aspects of the subject matter, functional area, and their assignments. They plan and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard engineering techniques, procedures and criteria and devises new approaches to problems encountered.
- Serve as support engineer for system level root cause investigation. Coordinate design improvements with development partners, long term planning strategy and implementation of design changes and improvements.
- Support system level design, development, and V&V work for commercial lifecycle management changes or in support of new project development
- A background in development and commercialization of medical devices and knowledge of manufacturing processes
- Risk Management – ISO 14971, EU Medical Device requirements – Council Directive 93/42/EEC
- Excellent (technical) written and verbal communication
- Ability to work independently and across functional teams
- Medical device industry experience and regulated work environment experience
- 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
- A Master’s or Bachelor’s degree in Biomedical / Mechanical / Electrical or related Engineering field and 3+ years of related engineering experience
Qualification & Experience:
- High school diploma/GED and 6 years of Engineering and/or Operations experience
- Associate’s degree and 4 years of Engineering and/or Operations experience
- Master’s Degree
- Bachelor’s Degree and 2 years of Engineering and/or Operations experience
Vacancy Type: Full Time
Job Functions: Engineering
Job Location: Thousand Oaks, CA
Application Deadline: N/A