Engineer Senior Biotech Combination Products - Hybrid JP13709
Engineer Senior Biotech Combination Products - Hybrid JP13709
Posted on :
13-04-2025
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1 Vacancy
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Hourly Salary
$ 44 - 48
Vacancy
1 Vacancy
Posted on :
13-04-2025
Job Description
Job 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 23 days per week onsite
3 Key Consulting is hiring! We are recruiting anEngineer Senior Biotech Combination Productsfor 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 sendyour resume to. Ifyou decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our websitewww.3keyconsulting/careers. You are also welcome to sharethis opportunity withanyone 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 23 days per week onsite
3 Key Consulting is hiring! We are recruiting anEngineer Senior Biotech Combination Productsfor 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
- 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 subtasks 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 crossfunctional 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 sendyour resume to. Ifyou decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our websitewww.3keyconsulting/careers. You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.
Regards
3KC Talent Acquisition Team
Employment Type
Hourly
Key Skills
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