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Engineer Senior, Biotech Combination Products - Hybrid (JP13709)
Thousand Oaks, CA · Biotech/PharmaceuticalJob Title: Engineer Senior, Biotech Combination Products - Hybrid (JP13709)
Location: Thousand Oaks, CA. 91320 (Hybrid)
Business Unit: Prefilled Syringes - New Product Development
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $44 - $48/hour W2 with benefits
Posting Date: 2/11/2025.
Notes: Onsite Thousand Oaks, CA - 2-3 days per week onsite
3 Key Consulting is hiring! We are recruiting an Engineer Senior, Biotech Combination Products for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:
B.S. and a minimum of 3+ strong years of experience. 5 YOE is ideal.
Experience working on prefilled syringes or vials. Combination product experience. Regulatory experience.
The Device Engineer will participate in the medical device/combination product design, development, and commercialization activities for drug delivery devices, focusing on prefilled syringes.
Key responsibilities include:
Red Flags:
Poor communication skills
Lack of hands on testing experience
Why is the Position Open?
Supplement to current team
Interview Process:
One rounds of interviews
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 (Hybrid)
Business Unit: Prefilled Syringes - New Product Development
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $44 - $48/hour W2 with benefits
Posting Date: 2/11/2025.
Notes: Onsite Thousand Oaks, CA - 2-3 days per week onsite
3 Key Consulting is hiring! We are recruiting an Engineer Senior, Biotech Combination Products for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:
B.S. and a minimum of 3+ strong years of experience. 5 YOE is ideal.
Experience working on prefilled syringes or vials. Combination product experience. Regulatory experience.
The Device Engineer will participate in the medical device/combination product design, development, and commercialization activities for drug delivery devices, focusing on prefilled syringes.
Key responsibilities include:
- Leading test procedure development and functional test execution
- Leading material inventory management for prefilled syringe programs, including material forecasting and material custody across multiple sites and functional groups.
- Authoring technical plans and reports
- Performing advanced statistical data analysis
- Supporting Leading technical assessments and root cause investigations as well as planning and delegation of sub-tasks to other team members.
- Transfer of information to manufacturing sites, engagement with suppliers
- Maintenance of Design History File content consistent with Good Documentation Practices
- Training junior staff on physical test methods, sample preparation protocols and procedures, and effective report writing.
- Reviewing primary data collected from peers in support for various design controls activities, including characterization and design verification.
- Supporting design transfer activities by leading cross-functional coordination of sample procurement and testing.
- Supporting the setting of specification limits for platform devices through human factors studies benchtop testing.
- 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).
- 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
- Pharma background.
- Physical testing experience
- Design controls experience
Red Flags:
Poor communication skills
Lack of hands on testing experience
Why is the Position Open?
Supplement to current team
Interview Process:
One rounds of interviews
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