Engineer, Medical Devices; JP

Position: Engineer, Medical Devices (JP12014)
Job Title:Engineer, Medical Devices (JP12014)
Location:Thousand Oaks, CA. 91320
Business Unit:PFS And Lyo Kit Platforms
Employment Type: Contract
Duration:1+ years with possible extensions or conversion to FTE
Rate
: $37 - $41/hour W2
Posting Date:11/29/2023
Notes:ONSITE - candidate is expected to be in mechanical lab and support.

3 Key Consulting is recruiting an
Engineer
for a consulting engagement with our direct client, a leading global biotechnology company.

Ideal Candidate
:
Force testing, good documentation and lab safety, technical writing, electronic data, Data verification i.e. what goes into reviewing technical documentation. Familiarity with Minitab and JMP. basic statistics, ANOVA and capability experience. Bachelor Degree and 2 years of experience. working in a mechanical lab. Familiarity with combination product development. Familiarity with design controls. specifically prefilled syringes.

Job Description:
The Device Engineer will participate in the design, development, and lifecycle management design control activities for commercialized drug delivery devices. This role includes technical operations support for combination product development to global launch, clinical and commercial manufacturing, failure investigation, design change evaluation, development and execution of test procedures, and continuous improvement initiatives.

Scope includes mechanical delivery devices, such as Prefilled syringes. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of these mechanical delivery devices are maintained. The engineer will participate in cross functional teams, leading device design activities such as the development of product enhancements, analytical failure analysis and implementation of design solutions, assessment of proposed changes, support product launches, and defend inspection and ensure the follow through of commitments.

Essential skills and Responsibilities:

• Adheres to strict documentation practices in a GMP regulated environment
• Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments, plans and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures and criteria and devises new approaches to problems encountered.
• Authors and reviews technical documentation including protocols, reports, and technical assessments
• Analyze and trend generated data by applying relevant statistical techniques to enable senior staff to make informed decisions
• Coordinates and executes laboratory testing to support characterization, verification, design transfer, and fill-finish efforts
• Maintains combination product design history files for assigned products
• Develops characterization test methods through fixture prototyping, reference sample creation, and GR&R analysis
• Provides functional subject matter expertise to actively participate in cross-functional activities including system level root cause analysis, design changes, and change control assessments
• Provide general laboratory support including inventory management, sample shipments, and cleanup.
• Works with Scientists and Engineers, to assess and develop appropriate design and manufacturing specifications
• Individual contributor with Leadership attributes to effectively represent device engineer within a large network/matrix organization
• At a minimum familiar with the following standards and regulations:
• Quality System Regulation – 21
  
  CFR
  820
• Risk Management – ISO 14971
• EU Medical Device requirements – Council Directive 93/42/EEC

Basic Qualifications:
Master degree
OR Bachelor degree and 2 years of experience
OR Associate degree and 6 years of experience

Preferred Qualifications:

• Bachelor’s Degree or higher in relevant engineering or scientific field (Mechanical, Biomedical, Bioengineering)
• Minimum 1 year of scientific or engineering experience in a GxP regulated environment
• Statistical Analysis software (Minitab or JMP)
• Strong technical writing skills
• CAD fixturing software (Solid Works)
• Instron force tester using Blue Hill Universal
• Experience with design controls;…