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.