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Engineer, Biotech Medical Device – Hybrid (JP13249)
Thousand Oaks, CA · Biotech/PharmaceuticalJob Title: Engineer, Biotech Medical Device – Hybrid (JP13249)
Location: Thousand Oaks, CA. 91320
Business Unit: Commercial Drug Product
Employment Type: Contract
Duration: 1+ years with possible extension or conversion to FTE
Rate: $38 - $42/Hours W2 with benefits
Posting Date: 10/15/2024
Notes: On site as needed.
We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:
The Device Engineer will participate in the design, development, and lifecycle management-related design center activities for commercialized drug delivery devices, including prefilled syringes. This includes technical operations support for failure investigations, leading and assessing design changes, test procedure development and execution, scale-up and global launch, contract manufacturing, supplier development, and continuous improvement of company’s combination product portfolio.
The qualified candidate will be part of a device engineering team that ensures design history files of mechanical and electro-mechanical delivery devices are well-maintained, and that company’s delivery device platform is well-utilized and expanded as necessary. The Device Engineer will participate in cross functional teams, lead device design activities such as developing product enhancements, perform analytical failure analysis and implement design solutions, assess proposed changes, support product launches, and defend inspection and follow through of commitments.
Top Must Have Skill Sets:
Day to Day Responsibilities:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience
Why is the Position Open?
Supplement additional workload on team.
Red Flags:
Interview Process:
Screening interview with hiring manager, followed by a panel interview. Following the panel interviews, if a tie-breaker is needed, there may be a 3rd final round to go in depth on specifics the team felt needed further discussion.
We invite qualified candidates to send your resume to recruiting@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.
Location: Thousand Oaks, CA. 91320
Business Unit: Commercial Drug Product
Employment Type: Contract
Duration: 1+ years with possible extension or conversion to FTE
Rate: $38 - $42/Hours W2 with benefits
Posting Date: 10/15/2024
Notes: On site as needed.
We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:
The Device Engineer will participate in the design, development, and lifecycle management-related design center activities for commercialized drug delivery devices, including prefilled syringes. This includes technical operations support for failure investigations, leading and assessing design changes, test procedure development and execution, scale-up and global launch, contract manufacturing, supplier development, and continuous improvement of company’s combination product portfolio.
The qualified candidate will be part of a device engineering team that ensures design history files of mechanical and electro-mechanical delivery devices are well-maintained, and that company’s delivery device platform is well-utilized and expanded as necessary. The Device Engineer will participate in cross functional teams, lead device design activities such as developing product enhancements, perform analytical failure analysis and implement design solutions, assess proposed changes, support product launches, and defend inspection and follow through of commitments.
Top Must Have Skill Sets:
- Problem solving (engineering skillset)
- Organization (self-starter and project level management)
- Communication (experience communicating at different levels and to different groups)
Day to Day Responsibilities:
- 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
- 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).
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience
Why is the Position Open?
Supplement additional workload on team.
Red Flags:
- Missing two or more of the following four items:
- Degree in the field of Mechanical or Biomedical.
- 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
- Inability to be present on site/support onsite based activities. This is a hybrid role, NOT fully remote
Interview Process:
Screening interview with hiring manager, followed by a panel interview. Following the panel interviews, if a tie-breaker is needed, there may be a 3rd final round to go in depth on specifics the team felt needed further discussion.
We invite qualified candidates to send your resume to recruiting@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.
Regards,
3KC Talent Acquisition Team