Senior Engineer (JP4894)
Thousand Oaks, CA.
Final Product Technology/Early Development
5+ months (likely extensions and/or conversion to permanent!)
3Key Consulting Inc. is recruiting for a Senior Engineer
with 2+ years’ experience in medical device and combination product development (design and development) and static/fluid dynamics knowledge for a global, CA-based, bio-pharmaceutical company.
Amgen is seeking a Sr. Engineer at its main headquarters in Thousand Oaks, CA to join the Final Product Technologies Early Development team. As a member of this organization, the Engineers’ work will focus on advancing a range of device technologies from traditional to novel as candidates for Amgen’s combination products portfolio. The scope of traditional technologies would include devices such as; fluid transfer devices, pen injectors, and micro-infuser delivery pump systems. The qualified candidate will ensure successful entry of these technologies into short-cycle robust device development. The Engineer will work closely with cross-functional team members and business stakeholders.
Top Must-Have Skill Sets:
Day to Day Responsibilities
- Engineering Knowledge (Combination product exp., Pharma background, Biomedical Engineering, Static Dynamics & Fluid Dynamics).
- Interpersonal Skills.
- Project Management Acumen - Need to understand basic project management skills.
- Interfacing with multiple Amgen project teams as the interim DTL. Ability to meet project team objectives and prepare and provide appropriate materials using established templates.
- Generate brand-specific drug delivery device technology roadmaps for new product introductions and lifecycle management.
- Serve as first and primary contact between product teams and Amgen's Final Product Technologies Organization.
- Responsible for engineering aspects of technology recommendations to brand teams.
- Communication of brand technology strategy and coordination within the Organization.
- Assist with identification and generation of inputs for strategic planning within the organization.
- Accumulate and review information on requisite design space for future device innovations.
- Assist with knowledge management advances to help communicate Device and Final Drug Product capabilities to the organization.
- Work with Amgen’s partners in the evaluation of device, diagnostics, and ancillary technologies.
Bachelor's Degree and 2 years of Engineering experience
Associate's degree and 6 years of Engineering experience
High school diploma/GED and 8 years of Engineering experience
Why This Position Is Open:
- BS in Biomedical, Mechanical, Materials, Electrical, Systems Engineering or similar.
- 2+ years' current experience in medical device / combination products development from concept through clinical introduction and commercialization.
- Experience in design and development of drug delivery devices for Europe and/or US (FDA/PMA/510k) submissions.
- Familiarity with intellectual property review and generation.
- Experience in database management or other IS (IT) functions.
- Experience working with cross-functional product teams.
- Experience interacting with external design, development, and manufacturing partners.
- Sufficient grasp of quality, risk management, regulatory, marketing, and clinical considerations to guide programs.
- Experience with technical evaluation of Amgen relevant technologies.
- Core design skills including: CAD, drawing development and standards, material selection, hand calculations and computational analysis, tolerance methods, Design for Six Sigma, Design for Manufacture.
- Working knowledge of strategic business considerations.
- Examples exhibiting decision making and organizational skills.
- Strong written and verbal skills in communication of technical material.
- Strong problem solving and risk management skills.
- Familiarity with the following standards: Quality System Regulation – 21CFR820 | Quality Management – ISO 13485 | Risk Management – ISO 14971 | EU Medical Device requirements – Council Directive 93/42/EEC | Medical Electrical Equipment – EN 60601.
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
- Capable of working on multiple projects in a deadline driven environment
Back fill for worker on maternity leave. Could potentially be extended.
Employee Value Proposition:
If this person does a good job there is a good chance this person could get extended or turn into FTE. Amgen is a world leader in this domain. Amgen is the only company in the world that has wearable injectors.
No engineering background.
Phone followed by in-person interview.
We invite qualified candidates to send your resume to email@example.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. You are also welcome to share this posting with anyone you think might be interested in applying for this role.