Senior Engineer (JP4894)​

Location: Thousand Oaks, CA
Date Posted: 10-25-2018
Job Title:  Senior Engineer (JP4894)
Location: Thousand Oaks, CA.
Employment Type:  Contract
Business Unit:  Final Product Technology/Early Development
Duration: 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.
 
Job Description:
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:
  • 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.
 
Day to Day Responsibilities
  • 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.
 
Basic Qualifications:
Basic Qualifications:
Master's Degree
OR
Bachelor's Degree and 2 years of Engineering experience
OR
Associate's degree and 6 years of Engineering experience
OR
High school diploma/GED and 8 years of Engineering experience
 
Preferred Qualifications:
  • 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
 
Why This Position Is Open:
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.
               
Red Flags:
No engineering background.
 
Interview process:
Phone followed by in-person interview.
 
We invite qualified candidates to send your resume to resumes@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. You are also welcome to share this posting with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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