Job Title: Device Engineer
Location: Thousand Oaks, CA
Pay rate: $41.07/ hr.
ZIP Code: 91320
Schedule: Hybrid
Start Date: Right Away
Keywords: #Engineer

The Device Engineer will participate in the design, development, and lifecycle management-related design center activities for commercialized drug delivery devices, including prefilled syringes. This includes technical operations support for failure investigations, leading and assessing design changes, test procedure development and execution, scale-up and global launch, contract manufacturing, supplier development, and continuous improvement of Client's combination product portfolio. The qualified candidate will be part of a device engineering team that ensures design history files of mechanical and electro-mechanical delivery devices are well-maintained, and that Client's delivery device platform is well-utilized and expanded as necessary. The Device Engineer will participate in cross functional teams, lead device design activities such as developing product enhancements, perform analytical failure analysis and implement design solutions, assess proposed changes, support product launches, and defend inspection and follow through of commitments.

Day to Day Responsibilities:
* Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments.
* Plans and conducts work requiring judgment in the independent evaluation, selection, and adaptation and modification of standard techniques/procedures/criteria, and devises new approaches to encountered challenges.
* Generates and maintains design specifications, protocol and report writing, prototyping, design of experiments/statistical process control product optimization, design verification & validation, FMEA, etc.
* System level root cause investigation
* Coordinate and implement design improvements with development partners.
* Collaborate with scientists and engineers internally and externally to assess and develop appropriate design and manufacturing specifications.
* Accountability of maintaining technical records within product design history files.
* Individual contributor with leadership attributes to effectively represent device engineering within a large network/matrix organization.
* Working proficiency and familiarity with governing standards and regulations, including Quality System Regulation (21CFR820) and Risk Management (ISO 14971).

Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
1. Degree in the field of Mechanical or Biomedical.
2. Medical device industry and/or regulated work environment experience.

Top 3 Must Have Skill Sets:
A. Problem solving (engineering skillset)
B. Organization (self-starter and project level management)
C. Communication (experience communicating at different levels and to different groups)


If you are interested in this role, please apply via the apply now link provided. Our overriding goal is to provide quality staffing solutions that help people, organizations, and communities succeed. Belcan is a leading provider of qualified personnel to many of the world's most respected enterprises. We offer excellent opportunities for contract, temporary, temp-to-hire, and direct assignments. We are the employer of choice for thousands worldwide. For more information, please visit our website at Belcan.com
EOE/F/M/D/V