Senior Engineer

Company: Aditi Consulting
Location: Newbury Park
Posted on: April 2, 2025

Job Description:

Payrate: $40.00- $43.00 /hr

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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.



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:

Pharma background.
Physical testing experience
Design controls experience



Pay Transparency:

The typical base pay for this role across the U.S. is: $40.00 - $43.00/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.



For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy (https://www.aditiconsulting.com/privacy-policy).



Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying to this position, you agree to Aditi's use of AI technology including calls from an AI Voice Recruiter.



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Keywords: Aditi Consulting, Los Angeles , Senior Engineer, Engineering , Newbury Park, California