Senior Engineer, Medical Drug Device Validation (JP4680)

Location: Thousand Oaks, CA
Date Posted: 08-31-2018
Job Title: Senior Engineer, Medical Drug Device Validation (JP4680)
Location: Thousand Oaks, CA
Employment Type: Contract
Duration: 24 months  with likely extensions
Business Unit: Mechanical Devices Team
3Key Consulting is looking for a Senior Engineer with sharp device and validation requirement protocols, for a leading, international pharmaceutical company headquartered in Thousand Oaks, CA

Only candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered.

  • Support 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 team members to 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.

• FDA regulation 21CFR820, i.e. QSR, GMP, Design Control
• Familiar with Risk Management Design/Process/Use FMEAs
• Design for Six Sigma (DFSS) MSA, and Design Capability

- 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
 - 5-7 years current experience with engineering processes and procedures.
- 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:
                        o Quality System Regulation 21CFR820
                        o Risk Management ISO 14971  
                        o 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 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 NOTE: Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered!!! 
DAY-TO-DAY RESPONSIBILITIES: Candidate should have minimal guidance and ability to make day to day decisions. Ability to detect and clear project challenges to meet deliverables on time.
RED FLAGS: Candidate that move from one company to another in a short period of time. Minimal experience in the 3 must have skills. Candidates with no medical design and design verification experience.
INTERVIEW PROCESS: Phone and in-person interview as soon as possible

We invite qualified candidates to send your resume to If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website You are welcome to also share this posting with anyone you think might be interested in applying for this role.**No Third-party Vendors Please**
3KC Talent Acquisition Team
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