Location: Thousand Oaks, CA
Date Posted: 04-04-2017
Ideal candidate would have a broad experience base that has an abstract holistic approach and can see the bigger picture and how it all connects- Project Management, technical writing ,Engineering, with exposure to Quality and Regulatory Affairs, and combination drug product/product design. 5 plus years in the Medical Device, Pharmaceutical, Biotechnology or other Healthcare-related field.

Candidates must be on-site at Thousand Oaks. Office space will be in cubicle, possibility of extensions, performance will be measured on set tasks/deliverables set and given by the manager.

The Device Engineer will support the combination product development platform project team as both a project manager and engineer. Scope includes improving the development process of Amgen combination products and combination product subassemblies. The qualified candidate will support the combination product development platform technical team to ensure successful completion of project tasks.

The Engineer will work closely with team members to develop and maintain project schedules, track deliverables, develop detailed engineering requirements documents, support verification, validation, and design characterization. The role of the Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support robust device development improvements.

BS in Mechanical Engineering and previous experience in a medical device, or similar industry, with 2 - 6 years current experience with engineering processes and procedures.
Experience in technical project management
Strong background in engineering of disposable medical devices.
Ability to model and analyze mechanical systems, assemblies, structures, linkages, and other mechanical engineering specialties.
Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
Experience in drug/device combination product design and development.
Familiarity with the following standards:
21CFR820 Quality System Regulation
21CFR820.30 Design Controls
ISO 14971 Risk Management
ISO 11608-1 Needle-based injection systems for medical use – Requirements and test methods – Part 1: Needle-based injection systems
EU Medical Device requirements
Medical Devices Directive 93/42/EEC

Preferred Qualifications:
5+ years of experience in the Medical Device, Pharmaceutical, Biotechnology or other Healthcare-related field;
Graduate degree with 2+ years of Project Management experience
Ability to work effectively in a fast paced, rapidly changing technology environment, and to manage technical activities around injection devices and combination products.
Ability to foster collaboration and work effectively on cross-functional teams

"This posting is for Contingent Worker, not an FTE"
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