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Engineer Senior, Drug Delivery Medical Device (JP9905)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title: Engineer Senior, Drug Delivery Medical Device (JP9905)
Location: Thousand Oaks, CA.
Employment Type:  Contract
Business Unit: Mechanical Autoinjectors Platform
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Posting Date: 3/2/2022

3 Key Consulting is hiring an Engineer Senior for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Support the teams in the development of drug delivery devices. Scope includes a wide range of devices, such as needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems. The qualified candidate will support technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices. The Sr. Engineer will work closely with device Subject Matter Expert (SME) to support develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices. The role of the Sr. Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.

Responsibilities include:
  • Work cross-functionally with individuals and project teams in Quality, Operations, and Development.
  • Create and assess product requirements to determine technical coverage and proper integration different subsystems.
  • Execute to project plans and schedules.
  • Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plans, verification and validation plans and other related product development documents for assigned projects.
  • Provide technical assistance for junior engineers.

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:
  • 5 years min experience in device engineering end to end configuration control management
  • Design characterization, verification execution.
  • Device design experience (design for six sigma experience a +)

Day to Day Responsibilities:
Support and manage day to day commercial advancement operation to ensure deliverables and deadlines are met. Coordinate activities and provide guidance to jr. engineers

Basic Qualifications:
  • BS in Engineering and previous experience in a medical device industry.
  • 10 years current experience with engineering processes and procedures.
  • Strong background in engineering and commercialization of electro-mechanical medical devices.
  • 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).
  • Experience in drug/device combination product design and development.
  • Familiar with the following standards:
    • Quality System Regulation 21CFR820 - Risk Management; ISO 14971 - EU Medical Device requirements; Council Directive 93/42/EEC - Medical Electrical Equipment; EN 60601 - Small scale device assembly experience.
  • Ability to read, analyze, and interpret general technical procedures, or governmental regulations.
  • Strong problem solving, risk assessment, and risk management skills.
  • Must be capable of working on multiple projects in a deadline driven environment.
  • VERY IMPORTANT NOTE: Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems Engineering background need apply and will be considered!!!

Employee Value Proposition:
Great biotech/pharma to work for.

Red Flags:
Applicants without 5 years of experience with one company.

Interview process:
Video Skype Panel Interview

We invite qualified candidates to send your resume to 
recruiting@3keyconsulting.com.  If you decide that you’re not interested in pursuing this position, please feel free to look at the other positions on our website https://3kc.catsone.com/careers/2010-General. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.

3KC Talent Acquisition Team
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