Engineer, Biomedical/Medical Device

Engineer, Biomedical/Medical Device - (JP11347)

Thousand Oaks, CA

Job Title: Engineer, Biomedical/Medical Device - (JP11347)
Location: Thousand Oaks, CA. 91320
Business Unit: Systems Engineering
Employment Type: 1 year contract 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/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 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 send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.