Medical Device Engineer Job at Planet Pharma, Thousand Oaks, CA

TnZzZnRjbTErR2Q4ZmRPZWFYL3dmdmhp
  • Planet Pharma
  • Thousand Oaks, CA

Job Description

617633

Our client, a leading Biotechnology company located in Thousand Oaks, CA, is looking for a Medical Device Engineer to participate in the design, development, and lifecycle management of 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.

Required Skills:

  • Bachelor’s Degree or higher in relevant engineering or scientific field (Mechanical, Biomedical, Bioengineering)
  • Understanding of Mechanical Design Engineering Concepts
  • Experience with Final Drug Product and/or Drug Product, medical device development, commercialization and knowledge of manufacturing processes (fill-finish)
  • Experience with design controls; including (but not limited to) design verification and transfer
  • Understanding of risk assessments including hazard and probability analysis
  • Experience with investigations and quality records
  • Laboratory and electronic lab notebook experience
  • Statistical Analysis software (Minitab or JMP)

Responsibilities:

  • Adheres to strict documentation practices in a GMP regulated environment
  • Engineering competency in all conventional aspects of the subject matter, functional area, and assignments
  • Plans and performs work, independently evaluating, selecting, and adapting standard methods, and creating new solutions to engineering problems.
  • 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
  • Analyze and trend generated data by applying relevant statistical techniques to enable senior staff to make informed decisions
  • Maintains device and combination product design history files for assigned products
  • Ensure test methods and test protocols are developed in a sound and robust framework with high focus on eliminating test errors
  • 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

***Compensation within this range will be commensurate with level of experience***

Job Tags

Similar Jobs

Trueline

Underground Utility Foreman Job at Trueline

 ...Trueline is seeking an MEP -Underground Utility Foreman to join their team in the Sioux Falls area. This role offers an exciting opportunity to lead crews and oversee critical infrastructure projects in a dynamic, growing industry. What You'll Do as the Underground... 

Pivot Physical Therapy

Physical Therapist Job at Pivot Physical Therapy

 ...Physical Therapist - Burlington, NC at Pivot Physical Therapy summary: As a Physical Therapist at Athletico in Burlington, NC, you will empower patients by enhancing their health and quality of life through exceptional care. You will work in a culture of teamwork and... 

GD Resources LLC

Safety Officer Job at GD Resources LLC

 ...express interest may be contacted for further discussions and evaluation as project details are finalized. JOB TITLE: Safety Specialist/Officer CLIENT/INDUSTRY: Infrastructure Development PLACE OF PERFORMANCE: Onsite at Hanover, Maryland DURATION: TBD RATE... 

Pace Life Sciences

Entry Level Microbiologist Job at Pace Life Sciences

 ...English, including spelling, grammar and punctuation. Required Skills: Performing intermediate to complex professional-level chemistry/biochemistry duties in a variety of assigned areas. Overseeing and administering various chemistry/biochemistry functions... 

Discover International

Clinical Data Manager Job at Discover International

 ...Hi Network, Our client is currently looking for 3 Clinical Data Managers to work on-site in Santa Monica/CA. The responsibilities are the following: Oversee and manage clinical trial data from initiation through closeout, ensuring accuracy, integrity, and compliance...