Medical Device Engineer

Job Title: Senior EngineerLocation: Thousand Oaks, CA (Hybrid)Duration: 12 MonthsDescriptionOnsite 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

Created: 2025-02-19