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Principal Engineer, Medical Device - Remote (JP9676)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title: Principal Engineer, Medical Device - Remote (JP9676)
Location: Thousand Oaks, CA 91320
Employment Type: Contract
Business Unit:  Final Product Technologies Quality
Duration: 12 months with likely extensions
Job posting date: 1/13/2022
Note: Remote

3 Key Consulting is hiring a Principal Engineer - Device design experience for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.

Job Summary:
  • Must have device design experience. This is a senior level role.
  • Have ample experience with combination products.
  • Need to understand the difference between verification/validation
  • Actually, have been a part of a combination product New Product Introduction effort not just to provide examples of what the company they are at have in their portfolio.
  • Able to describe trace matrix, and control plans, and their experience needs to be current, as consultants they bounce around allot and their experience might not be current.
  • Principal QUALITY Engineer – Development Quality.
  • Looking for human factors experience as well.
  • The Principal Quality Engineer – Development Quality is accountable for advice to, and oversight of, technical aspects in design control, and transfers. In addition, this role will be a single Quality point of contact for device design and related issues in development of combination and non-combination products.
  • Accountable for ensuring that Quality Systems identified for design and development of devices and combination products are appropriate and compliant for pre-commercial development activities.
  • Independently manages high complexity programs with greater risk to the business including those which are novel or new to Amgen, including electromechanical, and/or internally developed.
  • Responsible to represent FPTQ Development in external engagements. Provides oversight of proper quality resource balancing on project(s) as required, ensuring FPTQ resources are proactively managed.
  • Reviews and approves Design History File (DHF) content and technical documentation and assessments throughout the design & development lifecycle, including content from suppliers and partners.
  • Participates in definition and development of final product requirements, in particular for specialized products.
  • Approves device components and final product or the device constituent of a combination product specification as part of development program.
  • Establishes the quality requirements for development process to transfer design.
  • Participates in technical aspects of problem-solving, complaints, and other investigations in relevant design control phases.
  • Participates in non-design control investigations on an as needed basis.
  • Responsible for creation, updating, and maintenance of Traceability Matrix.
  • Develops and maintains final product quality plan.
  • Quality approval at all key design phases (i.e. verification, validation, development, and launch readiness) and key participant at design reviews. Quality approver of the Design History File.
  • Ensures that all Quality Requirements have been met and DHF is ready for Prior Approval Inspections (PAIs), Inspection Readiness Activities, and Partner Audits. Obtains, reviews, and confirms readiness of documentation for inspections.
  • Ensure control strategies have been established, implemented, and maintained throughout the design and development lifecycle.
  • Represents FPTQ at TCP or External Engagement initiatives as necessary.
  • Acts as delegate for head of FPTQ Development Quality as needed.
  • Supports development of program-related quality agreements.
  • Participates in generation of development agreements with third parties.

Top Must have Skill Sets:
  • Medical Device Design Validation
  • Medical Device Design Verification
  • Quality experience including change control, design controls, risk assessment and management, and root cause analysis.

Employee Value Proposition:
Work with a team of industry experts at one of the top biopharmaceutical companies, assist with meaningful products that make lasting impacts. Expand work experience and skill sets, possible extension.

Red Flags:
No device experiences
No QA experience

Interview Process:
First round phone screen and then 1-2 more rounds


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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