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Engineer Senior, Drug Device  (JP7329)

Thousand Oaks, California · Biotech/Pharmaceutical
Job Title:  Engineer Senior, Drug Device  (JP7329)
Location: Thousand Oaks, CA. (Remote then onsite pending lifting of COVID restrictions)
Employment Type:  Contract
Business Unit: Commercial Product Engineering
Duration: 12 months with likely extensions
Posting Date: 6/1/20
 
3 Key Consulting is hiring a Senior Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.
 
Job Description:
Ideal candidate:
Someone who has a experience in medical devices and/or combination products. At least 5 years of experience. Someone proactive and independent and can work at a fast pace.

This role will support project teams in the design, development and life cycle management of drug delivery devices. This includes technical operations support for design control activities, contract manufacturing, failure investigation, leading and assessing design changes, development of test procedures, scale-up, and continuous 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 the 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.
 
Responsibilities:
  • Work cross-functionally with individuals and within project teams to provide technical assistance to projects.
  • Develop and maintain technical records within design history file associated with assigned products.
  • Develop test methods, generate and maintain design specification, protocol & report writing, prototyping, DOE/SPC product optimization, design verification & validation, FMEA, design transfer, etc.
  • Support system level root cause investigation, design improvements with development partners, strategic planning and execution of design changes and improvements.
  • Work with Scientists and Engineers internally and externally to assess and develop appropriate design and manufacturing specifications.
 
Skills:
  • BS in Engineering (Mechanical / Industrial / Biomedical) and previous experience in a medical device, or similar industry, with 5 - 10 years current experience with engineering processes and procedures.
  • Strong background in engineering of electro-mechanical and disposable medical devices and combination products.
  • Ability to model and analyze mechanical systems, fluid flow, stress, assemblies, structures, linkages, heat transfer and other mechanical engineering specialties.
  • 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.
  • Familiarity with the following standards:
    • 21CFR820 Quality System Regulation
    • ISO 14971 Risk Management
    • EU Medical Device requirements
    • Medical Devices Directive 93/42/EEC
    • Medical Electrical Equipment
    • EN 60601
  • 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.
 
Top Must-Have Skill Sets:
  • BS in Engineering (Mechanical or Industrial or Biomedical).
  •  Previous experience in a medical device, or similar industry, with 5 - 10 years current experience with engineering processes and procedures.
  • Expertise in technical documentation (protocol & report writing), design verification & validation, FMEA, design transfer, root cause investigation, design improvement and product optimization, etc
 
Day to Day Responsibilities:
  • Work cross-functionally with individuals and within project teams to provide technical assistance to projects.
  • Develop and maintain technical records within design history file associated with assigned products.
  • Develop test methods, generate and maintain design specification, protocol & report writing, prototyping, DOE/SPC product optimization, design verification & validation, FMEA, design transfer, etc.
  • Support system level root cause investigation, design improvements with development partners, strategic planning and execution of design changes and improvements.
  • Work with Scientists and Engineers internally and externally to assess and develop appropriate design and manufacturing specifications.
  
Employee Value Proposition:
This team is unique in which they deal with all final products and devices. Reconfigure all medical devices and work with a lot of teams to be able to work and grow within the company.

Red Flags:
  • Non-engineering educational qualification
  • No direct experience with medical devices and/or combination products
  • Relevant work experience of less than 5 years
  • Job hopping
Interview process:
Phone interview followed by video interview for short-listed candidate(s). Interview process will start immediately.
 
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.

 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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