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Engineer Senior, Mechanical / Electro-mechanical (JP7352)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:  Engineer Senior, Mechanical / Electro-mechanical  (JP7352)
Location: Thousand Oaks, CA.
Employment Type:  Contract
Business Unit:  Wearable Injector Platform Team
Duration: 1+ years (with likely extensions)
 
3 Key Consulting is hiring a Engineer Senior for a consulting engagement with our direct client, a leading global biopharmaceutical company.
 
Job Description:
Our ideal candidate will have a Mechanical or Electro-mechanical degree. Strong understanding and experience in design controls, failure investigation. Medical device industry experience and regulated work environment experience. Must have at least 2 years current industry experience.
 
The Senior Device Engineer will participate in lifecycle management related to commercialized drug delivery devices. This includes technical operations support for contract manufacturing, failure investigation, leading and assessing design changes, develop test procedures, scale-up and global launch, supplier development, and continues improvement.
 
Scope includes mechanical and electro-mechanical delivery devices, such as fluid transfer devices, automatic pen injectors, and micro-infuser delivery pump systems. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of these mechanical and electro-mechanical delivery devices are maintained. The Engineer will participate in cross functional teams, leading device design activities such as developing product enhancements, analytical failure analysis and implementing design solutions, assessment of proposed changes, product launches, and defending inspection and follow through of commitments.
 
The position is located in Thousand Oaks, CA and requires up to 10% domestic and international travel.
 
 
Why is the Position Open?
Supplement additional workload on team.
 
 
Top Must-Have Skill Sets:
  • Mechanical or Electro-mechanical degree is preferred.
  • Strong understanding and experience in design controls, failure investigation.
  • Medical device industry experience and regulated work environment experience
 
Day to Day Responsibilities:
  • Accountability of maintaining technical records within design history file associated with assigned products.
  • Develop Test Method, generate and maintain design specification, protocol & report writing, 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 network/matrix organization.
 
 
Basic Qualifications:
Doctorate Degree
OR
Master’s degree and 3 years of Engineering or Operations experience
OR
Bachelor’s degree and 5 years of Engineering or Operations experience
OR
Associate’s degree and 10 years of Engineering or Operations experience
OR
High School Diploma/GED and 12 years of Engineering or Operations experience
 
 
Preferred Qualifications:
  • Mechanical or Electro-mechanical 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.
    • EU Medical Device requirements – Council Directive 93/42/EEC
 
 
Employee Value Proposition:
The Senior Device Engineer will participate in lifecycle management related to commercialized drug delivery devices. This includes technical operations support for contract manufacturing, failure investigation, leading and assessing design changes, develop test procedures, scale-up and global launch, supplier development, and continues improvement.
 
 
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.
 
 
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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