Engineer Senior Drug Delivery DevicesDevelopment Commercialization JP13860

Job Title: Engineer Senior Drug Delivery Devices/Development & Commercialization (JP13860
Location: Thousand Oaks CA. 91320 (Hybrid)
Business Unit: Prefilled Syringes & Kit Platform
Employment Type: Contract
Duration: 1 year with likely extensions and/or conversion to a permanent position.
Rate: $45 $50/hour W2
Posting Date: 03/18/2025.
Notes: Only qualified candidates need apply. Onsite in Thousand Oaks CA 23 days per week onsite.


3 Key Consulting is hiring! We are recruiting an Engineer Senior Drug Delivery Devices for a consulting engagement with our direct client a leading global biotechnology company.

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

The ideal candidate will have a 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.

Top Must Have Skill Sets:
Pharma background.
Physical testing experience
Design controls experience

Day to Day Responsibilities:
Leading test procedure development and functional test
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 subtasks 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 crossfunctional coordination of sample procurement and testing.
Supporting the setting of specification limits for platform devices through human factors studies benchtop testing.

Essential Skills:
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
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 skills
Understanding and experience in:
o Development/commercialization of medical devices and knowledge of manufacturing processes
o Initiating and bringing complex projects to conclusion
o Ability to work independently and dynamic cross functional teams
o Design controls
o Failure investigation
o Applied statistics

Red Flags:
Poor communication skills
Lack of hands on testing experience

Why is the Position Open
Planned Project

Interview Process:
One round of interviews.

We invite qualified candidates to send your resume to If you decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our website www.3keyconsulting/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.