Job Title:   Engineer Senior - Biopharma Medical Device (JP9881)
Location: Thousand Oaks, CA.
Employment Type:  Contract
Business Unit: FPT Development Product Engineering
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Posting Date: 2/24/2022
Notes:  Preferred to be onsite, but in special cases could be remote.

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

Job Description:
Lead 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 lead technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices. The Principal 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 Principal Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development. Responsibilities include:

• 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.

Why is the Position Open?
planned project.

Top Must Have Skills:

• Design controls.
• Mechanical testing.
• Drug delivery experience.
• Risk base process.
• Presentation skills.

Day to Day Responsibilities:

• Author device documentation to support development, planning, verification, validation, and transfer.
• Author test protocols and execute mechanical testing of drug delivery devices.
• Presentation and communication skills (within program teams).
• Execute and deliver within regulated development processes.
• Proactively maintains close communication with technical leads.

Basic Qualifications:

• BS in Engineering 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 following standards:
  • Quality System Regulation (21CFR820 o 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.
• 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.

Red Flags:

• Less than 5 years of experience,
• Jumpy job history,
• Lack of enthusiasm and not self-motivated

Interview process:
Video Skype Panel 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.