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Engineer, Drug Device Combination Product – Prefilled Syringes / Hybrid (JP13580)
Thousand Oaks, CA · Biotech/PharmaceuticalJob Title: Engineer, Drug Device Combination Product – Prefilled Syringes / Hybrid (JP13580)
Location: Thousand Oaks, Ca.
Business Unit: Prefilled Syringes And Lyo Kit Platforms
Employment Type: Contract
Duration: 12 months with likely extensions or conversion to perm
Rate: $36-41/hours W2 with benefits
Posting Date: 1/28/2025
Target Start Date: 2/3/2025
3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:.
The Device Engineer will play a critical role in the design, development, and lifecycle management of drug delivery devices, including prefilled syringes, with a focus on testing and analysis within a laboratory environment. This position requires strong experimental, analytical, and statistical skills to support technical operations and ensure the success of the company’s combination product portfolio.
Essential skills and Responsibilities:
Top Must Have Skill Sets:
Day to Day Responsibilities:
Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
Red Flags:
Missing two or more of the following four items:
1. Degree in the field of Mechanical or Biomedical.
2. Medical device industry and/or regulated work environment experience.
3. Excellent written and verbal communication skill.
4. 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
Additional stand-alone red flag: inability to be present on site/support onsite based activities. This is a hybrid role, NOT fully remote.
Interview Process:
Screening interview with myself, 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.
Business Unit: Prefilled Syringes And Lyo Kit Platforms
Employment Type: Contract
Duration: 12 months with likely extensions or conversion to perm
Rate: $36-41/hours W2 with benefits
Posting Date: 1/28/2025
Target Start Date: 2/3/2025
3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:.
The Device Engineer will play a critical role in the design, development, and lifecycle management of drug delivery devices, including prefilled syringes, with a focus on testing and analysis within a laboratory environment. This position requires strong experimental, analytical, and statistical skills to support technical operations and ensure the success of the company’s combination product portfolio.
Essential skills and Responsibilities:
- Conducting hands-on experimental testing to support failure investigations and root cause analysis.
- Developing, executing, and refining test procedures to evaluate device performance and functionality.
- Analyzing test data and applying statistical methods to derive actionable insights and recommendations.
- Supporting design changes by leading testing efforts to assess and validate proposed modifications.
- Participating in the scale-up, global launch, and continuous improvement of drug delivery devices.
- Collaborating with contract manufacturers and suppliers to ensure device quality and performance standards are met.
- Maintaining robust design history files for mechanical and electro-mechanical delivery devices.
- Enhancing and expanding company’s delivery device platform as needed to meet evolving product and regulatory requirements.
The ideal candidate will: - Have strong laboratory testing experience, particularly with combination products and medical devices.
- Possess a solid foundation in experimental methods and data analysis.
- Be proficient in statistical tools and methodologies.
- Demonstrate experience in failure analysis and implementing design solutions.
- Have a proven ability to collaborate effectively within cross-functional teams.
- Exhibit strong organizational skills and attention to detail, especially in maintaining design history files.
- Show familiarity with regulatory and quality requirements for combination products and medical devices.
- This role offers the opportunity to make a meaningful impact by leveraging technical expertise in a dynamic and innovative environment focused on advancing the company’s portfolio of drug delivery devices.
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).
Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
Red Flags:
Missing two or more of the following four items:
1. Degree in the field of Mechanical or Biomedical.
2. Medical device industry and/or regulated work environment experience.
3. Excellent written and verbal communication skill.
4. 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
Additional stand-alone red flag: inability to be present on site/support onsite based activities. This is a hybrid role, NOT fully remote.
Interview Process:
Screening interview with myself, 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