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Engineer Senior, Drug Device Technology (JP7546)

Thousand Oaks, California · Biotech/Pharmaceutical
Job Title:  Engineer Senior, Drug Device Technology (JP7546)
Location: Thousand Oaks, CA. (Remote then onsite pending lifting of COVID restrictions)
Employment Type:  Contract
Business Unit: Device Strategy Technology Assessment
Duration: 12 months with likely extensions or conversion to FTE
Posting Date: 8/11/20
3 Key Consulting is hiring a Senior Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:
   Candidate will be working remote until the site reopens
   Min Bachelors Degree in Engineering

   5+ years of experience within Pharma, Biotech, Med Device

Lead 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 lead technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices. The Senior Engineer will work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices. The role of the Senior Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.
  • Work cross-functionally with individuals and project teams in Marketing, Operations, and Development
  • Create and assess product requirements to determine technical coverage and proper integration different subsystems.
  • Create and execute to project plans and schedules
  • Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects.
  • Provide deep technical assistance for junior engineers.
  • BS in Engineering and previous experience in a medical device industry
  • Led projects from development through the 510k and PMA approval process.
  • 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) 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
  • Familiar with the following standards:
    • Quality System Regulation
    • 21CFR820 o Risk Management
    • ISO 14971 o EU Medical Device requirements
    • Council Directive 93/42/EEC o Medical Electrical Equipment
    • EN 60601 - Small scale device assembly experience.
  • Ability to read, analyze, and interpret general business periodicals, professional journals, 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

Top Must-Have Skill Sets:
  • design controls
  • mechanical testing
  • drug delivery experience
  • risk base process
  • presentation skills
Day to Day Responsibilities:
  • Author device documentation to support development, planning, verification, validation, and transfer
  • Author test protocols and execute mechanical testing of drug delivery devices
  • Presentation and communication skills (within program teams)
  • Execute and deliver within regulated development processes
  • Proactively maintains close communication with technical leads
Employee Value Proposition:
Opportunity to gain exposure to design control and design transfers within a quality regulated environment. Fast pace & high exposure.

Red Flags:
Less than 5 years of experience, jumpy job history
Interview process:
3-4 interviews with hiring manager and key stakeholders
virtual: phone/video based only
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/careers. You are welcome to also welcome to share this opportunity with anyone you think might be interested in applying for this role.
3KC Talent Acquisition Team
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