Job Description:

Location: Thousand Oaks, CA

Salary: $35.00 USD Hourly - $41.00 USD Hourly

Description:

Position Title : Device Engineer



Location : Thousand Oaks, CA 91320



Duration : 12+ Months contract




Description:



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 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 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.


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


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)


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).

Contact: hsharma04@judge.com


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