Engineer Senior Biotech Combination Products - Hybrid JP13322
Engineer Senior Biotech Combination Products - Hybrid JP13322
Posted on :
05-04-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Hourly Salary
$ 44 - 48
Vacancy
1 Vacancy
Posted on :
05-04-2025
Job Description
Job Title: Engineer Senior Biotech Combination Products Hybrid (JP13322
Location: Thousand Oaks CA. 91320 (Hybrid)
Business Unit: Device Strategy Technology Assessment
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: 10/22/2024.
Notes: Only qualified candidates need apply. Hybrid 3 days onsite working primarily onsite in Thousand Oaks with ability to work remotely. Bachelors Degree in Engineering. 5 years of experience within Pharma Biotech Med Device
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:
Responsible for planning executing and reporting test activities for combination product teams. Coordinates with technical leads and cross functional teams to ensure deliverables needed for device design feasibility characterization and verification stages are completed on time with high quality standards.
Scope includes a wide range of devices such as: needle protection systems fluid transfer devices pen injectors automatic pen injectors. The qualified candidate will coordinate with technical teams to ensure successful device development of these medical devices. The Senior Engineer will work closely with team members to develop detailed engineering deliverable timelines directing and monitoring work efforts on a daily basis identifying resource needs; and escalating functional quality timeline issues appropriately. The qualified candidate will support verification validation and regulatory submissions of these devices. Work within a crossfunctional organization to utilize technologies and methodologies that support shortcycle robust device development.
Responsibilities include:
Top Must Have Skill Sets:
Day to Day Responsibilities:
Basic Qualifications:
Red Flags:
Less than 5 years of experience jumpy job history.
Why is the Position Open
Supplement to current team
Interview Process:
2 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: Device Strategy Technology Assessment
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: 10/22/2024.
Notes: Only qualified candidates need apply. Hybrid 3 days onsite working primarily onsite in Thousand Oaks with ability to work remotely. Bachelors Degree in Engineering. 5 years of experience within Pharma Biotech Med Device
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:
Responsible for planning executing and reporting test activities for combination product teams. Coordinates with technical leads and cross functional teams to ensure deliverables needed for device design feasibility characterization and verification stages are completed on time with high quality standards.
Scope includes a wide range of devices such as: needle protection systems fluid transfer devices pen injectors automatic pen injectors. The qualified candidate will coordinate with technical teams to ensure successful device development of these medical devices. The Senior Engineer will work closely with team members to develop detailed engineering deliverable timelines directing and monitoring work efforts on a daily basis identifying resource needs; and escalating functional quality timeline issues appropriately. The qualified candidate will support verification validation and regulatory submissions of these devices. Work within a crossfunctional organization to utilize technologies and methodologies that support shortcycle robust device development.
Responsibilities include:
- Create and maintain project timelines.
- Ensures that the product development process abides by all defined crossfunctional standards meets the intent and letter of SOPs and all compliance and regulatory needs of the applicable markets.
- Identifies early and solves complex and ambiguous crossfunctional integration problems leading the team to deliver per Product team commitments including (but not limited to) completing functional goals adjustments/iterations and crossfunctional teamwork.
- Works with the Program Manager to ensure effective and efficient communication and for the duration of the crossfunctional program team.
- Works with the system subsystem/platform supply chain service QA RA Research project leaders to deliver quality products on time within budget and with the necessary features/functionality.
- Develop execute and review architecture documents design documents specifications development plans characterization plan verification and validation plans and other related product development documents for assigned projects.
- Provide deep technical assistance for junior engineers.
Top Must Have Skill Sets:
- Testing experience
- Product Development
- Experience with design controls and medical device regulations
- Drug delivery/combination product experience
- Riskbased process
- Presentation skills
Day to Day Responsibilities:
- Author device documentation to support development planning verification validation and transfer
- Author test protocols and execute mechanical testing of drug delivery devices
- Presentation and communication skills (within program teams)
- Execute and deliver within regulated development processes
- Proactively maintains close communication with technical leads
Basic Qualifications:
- Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience.
- Bachelors / Masters Degree in Electrical/Mechanical /Biomedical Engineering Computer Engineering or equivalent experience
- Medical device and/or combination product development experience; design controls experience
- 5 years of more progressive responsibility and experience as an engineer or scientist
- Demonstrated ability to build lasting crossfunctional relationships including strong influential and communication skills
- Demonstrated understanding/experience with the New Product Introduction (NPI) cycle and crossfunctional interdependencies
- Familiarity with test equipment such as Instron.
Red Flags:
Less than 5 years of experience jumpy job history.
Why is the Position Open
Supplement to current team
Interview Process:
2 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
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
