Engineer, Biomedical​/Medical Device JP

Position: Engineer, Biomedical/Medical Device - (JP11347)
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 on-site 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 execution
• 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/Solid Works 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 (21
  
  CFR
  820) 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 cross-functional team environment
• Poor communication and technical writing skills
• Many positions in a short time frame (e.g. 3 per year)
• Interested in remote-only; this job requires on-site attendance

We invite qualified candidates to sendyour resume  Ifyou decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our  You are also welcome to sharethis opportunity with anyone you think might be interested in applying for this role.

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