Engineer

1 week ago

Thousand Oaks, United States Aditi Consulting Full time
Summary:
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.

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 - 21CFR820
  • Risk Management - ISO 14971
  • EU Medical Device requirements - Council Directive 93/42/EEC

Preferred Qualifications:
  • Bachelor's Degree or higher in relevant engineering or scientific field (Mechanical, Biomedical, Bioengineering)
  • Minimum 2 year of scientific or engineering experience in a GMP regulated environment
  • Statistical Analysis software (Minitab or JMP)
  • Strong technical writing skills
  • CAD fixturing software (SolidWorks)
  • Instron force tester using BlueHill Universal
  • Experience with design controls; including (but not limited to) verification and design transfer
  • Understanding of risk assessments including hazard and probability analysis
  • Background in medical device development, commercialization and knowledge of manufacturing processes (fill-finish)
  • Ability to work independently and dynamically across functional teams
  • Excellent written and verbal communication skills
  • Ability to support complex workstreams under demanding timelines

Top 3 Must Have Skill Sets:
  • Authors and reviews technical documentation including protocols, reports, and technical assessments
  • Coordinates and executes laboratory testing to support characterization, verification, design transfer, and fill-finish efforts
  • 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.

Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate's qualifications, skills, competencies, experience, location and end client requirements).

Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.

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.

#AditiConsulting

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