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Engineer Senior - (JP9303)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:  Engineer Senior - (JP9303)
Location: Thousand Oaks, CA.
Employment Type:  Contract
Business Unit: Final Product Technologies Commercial Advancement
Duration: 1+ years (with likely extensions)
Notes: Onsite
Posting Date:  10/15/2021

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

Job Description:
The Senior Engineer participates in the lifecycle management activities of commercialized electromechanical drug delivery devices, with focus on wearable micro-infuser delivery systems. Activities include leading failure investigation, assessing design changes for continuous improvement and supporting global launch.

The responsibilities include the technical assessment of returned unit investigation reports to identify potential root cause and to properly classify records for future complaints data analysis. Also includes representing the device engineering group in cross functional teams that assess complaint records requiring further actions.

The Sr. Engineer position is part of a sustaining engineering team that ensures design history files are maintained. Will also lead root cause analysis sessions and document CAPA activities with a cross functional team, as well as selecting and leading design change development and product launch activities. Will also represent the team in inspections and follow through with commitments made.

The position is located in Thousand Oaks, CA and may require up to 10% domestic and international travel.

Top Must-Have Skill Sets:
  • Mechanical or Electrical degree is preferred
  • Medical device industry and regulated work environment experience
  • Experience in design controls

Day to Day Responsibilities:
  • Accountability for maintaining technical records within design history file of assigned products.
  • Develop Test Method, generate and maintain design specification, protocol & report authoring, prototyping, DOE/SPC product optimization, design verification & validation, FMEA, etc.
  • Lead system level root cause investigation, coordinate design improvements with development partners, strategic planning and execution of design changes and improvements.
  • Works with Scientists and Engineers internally and externally to assess and develop appropriate design and manufacturing specifications.
  • Develop and maintain Electromechanical devices including hardware and software.
  • Individual contributor with Leadership attributes to effectively represent device engineer within a large organization.

Basic Qualifications:
Doctorate Degree
Master’s degree and 3 years of Engineering or Operations experience
Bachelor’s degree and 5 years of Engineering or Operations experience
Associate’s degree and 10 years of Engineering or Operations experience
High School Diploma/GED and 12 years of Engineering or Operations experience

Preferred Qualifications:
  • Mechanical or Electrical degree is preferred
  • Medical device industry experience and regulated work environment experience
  • Background in developing and commercialization of medical devices and knowledge of manufacturing processes
  • Strong understanding and experience in design controls, failure investigation, initiating and bringing complex projects to conclusion and the ability to work independently and dynamic cross functional teams are required
  • Excellent written and verbal communication skills required.
  • Familiarity with the following standards and regulation:
    • Quality System Regulation – 21CFR820
    • Risk Management – ISO 14971
    • Regulation (EU) 2017/745 on medical devices

Red Flags:
  • No prior experience with design control of medical devices.
  • No experience in root cause investigations
  • Must have electro-mechanical background or do not submit

Interview process:
Phone screening 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/careers. You are 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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