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Senior Engineer - Biotech Medical Device/Drug Product (JP7732)

Thousand Oaks, ca · Biotech/Pharmaceutical
Job Title: Senior Engineer - Biotech Medical Device/Drug Product  (JP7732)
Location: Thousand Oaks, CA    
Employment Type: Contract
Duration: 6 months with likely extensions
Job posting date: 10/2/2020
Note: working on site 25% of the time

3 Key Consulting is hiring a Project Manager for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
Job Summary:
  • Work in 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 be key support member on 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 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.
  • Execution of documentation and testing for new products in the process of launch
  • Technical support and direction for cross functional team
  • Participate in team meetings and reviews
  • Report progress, achievements, and challenges in a timely manner
  • BS in Engineering or equivalent and previous experience in a medical device industry
  • 10 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 standards: Quality System Regulation , 21CFR820 , Risk Management ,ISO 14971, 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.
  • VERY IMPORTANT: Must be capable of working on multiple projects in a deadline driven environment.
  • Bachelor’s Degree - Bioengineering, mechanical engineering, chemical engineering

Top Must have Skill Sets:
  • Demonstrated knowledge of medical device and/or combination product regulations and standards (design Control, risk management) (5 years of experience)
  • Experience working at least 2 years in medical device and/or combination product development or manufacturing (3-5 years of experience)
  • Experience with test method qualification (3-5 years of experience)
Employee Value Proposition:
gaining experience in combination product device, cross collaboration between medical devices and pharma departments, and growing your skill set.
Red Flags:
Frequent job changes
No direct medical device/combination product experience
Interview Process:
Phone interviews with 3 interviewers 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.
3KC Talent Acquisition Team

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