Engineer Senior at The Judge Group Inc. in Thousand Oaks, California

Job Description:

Location: Thousand Oaks, CA

Salary: $40.00 USD Hourly - $55.00 USD Hourly

Description:

Senior Engineer




1+ year contract




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

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Contact: tsultan@judge.com


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