drjobs Engineer BiomedicalMedical Device - JP11347

Engineer BiomedicalMedical Device - JP11347

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Job Location drjobs

Thousand Oaks, CA - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Job Title: Engineer Biomedical/Medical Device (JP11347
Location: Thousand Oaks CA. 91320
Business Unit: Systems Engineering
Employment Type:1 yearcontract to hire.
Posting Date: 03/13/2023
Notes: Only qualified candidates need apply. Job requires onsite attendance. Shift/Schedule: Monday Friday 8am 5pm (ATO).


3 Key Consulting is recruiting an Engineer for a consulting engagement with our direct client a leading global biopharmaceutical company.

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.

Top Must Have Skill Sets:
  • Hands on Laboratory Experience in a GLP Setting 1 years of experience.
  • Good Communication and Technical Writing Skills
  • Ability to Multitask
  • Must have BS degree Mechanical or Biomedical Engineering or related field.

Day to Day Responsibilities:
  • Test procedure development and functional test
  • Authoring technical plans and reports
  • Performing statistical data analysis
  • Supporting technical assessments and root cause investigations
  • Transfer of information to manufacturing sites engagement with suppliers
  • Maintenance of Design History File content consistent with Good Documentation Practices

Basic Qualifications:
  • 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

Red Flags:
  • No laboratory experience or desire to work in a lab environment (not considering less than a year)
  • No desire to work in crossfunctional team environment
  • Poor communication and technical writing skills
  • Many positions in a short time frame (e.g. 3 per year)
  • Interested in remoteonly; this job requires onsite attendance


We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our websitewww.3keyconsulting/careers. You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.

Employment Type

Full Time

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