Device Engineer

Thousand Oaks, California

ACL Digital
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Title: Senior Engineer

Location : Thousand Oaks CA 91320

Duration : 12 months; possible extension

Description

Onsite Thousand Oaks, CA - 2-3 days per week onsite.

B.S. and a minimum of 3+ strong years of experience. 5 YOE is ideal.

Nice to have: someone who has experience working on prefilled syringes or vials. Combination product experience. Regulatory experience.

The Device Engineer will participate in the medical device/combination product design, development, and commercialization activities for drug delivery devices, focusing on prefilled syringes.

Key responsibilities include:

Leading test procedure development and functional test execution

Leading material inventory management for prefilled syringe programs, including material forecasting and material custody across multiple sites and functional groups.

Authoring technical plans and reports

Performing advanced statistical data analysis

Supporting Leading technical assessments and root cause investigations as well as planning and delegation of sub-tasks to other team members.

Transfer of information to manufacturing sites, engagement with suppliers

Maintenance of Design History File content consistent with Good Documentation Practices

Training junior staff on physical test methods, sample preparation protocols and procedures, and effective report writing.

Reviewing primary data collected from peers in support for various design controls activities, including characterization and design verification.

Supporting design transfer activities by leading cross-functional coordination of sample procurement and testing.

Supporting the setting of specification limits for platform devices through human factors studies benchtop testing.

Essential Skills:

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; CAD/SolidWorks proficiency; tolerance analysis; capability analysis.

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).

Preferred Qualifications:

Degree in the field of Mechanical or Biomedical Engineering, or related field

Medical device industry and/or regulated work environment experience

Excellent written and verbal communication skill

Understanding and experience in:

Development/commercialization of medical devices and knowledge of manufacturing processes

Initiating and bringing complex projects to conclusion

Ability to work independently and dynamic cross functional teams

Design controls

Failure investigation

Applied statistics

Basic Qualifications

Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma/GED and 12 years of experience

Top 3 Must Have Skill Sets:

  1. Pharma background.

  1. Physical testing experience

  1. Design controls experience
Date Posted: 12 May 2025
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