Engineer Senior, Medical Device Root Cause Investigations; JP

Position: Engineer Senior, Medical Device Root Cause Investigations (JP13462)
Job Title: Engineer Senior, Medical Device Root Cause Investigations (JP13462)
Location: Thousand Oaks, CA. 91320
Business Unit: Mechanical Autoinjectors Platform
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $44 - $50/hour W2
Posting Date: 1/213/2025.
Notes: Only qualified candidates need apply. 80% Onsite

3 Key Consulting is hiring! We are recruiting a Engineer Senior, Medical Device Root Cause Investigations for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Our ideal candidate will have a B.S. and 5+ YOE experience in root cause investigations, change controls, deviations, and CAPA. Having Minitab and Pharma or med device background is a plus!

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;

• 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 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.

Top Must Have Skill Sets:

• Previous experience in medical devices/pharma

• Project management

• Good Documentation Practices

Day to Day Responsibilities:
Worker must be able to accomplish given tasks with minimal supervision. Expectation is that worker will lead projects to completion and work cross functionally to overcome any technical hurdles.

• 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.

Basic Qualifications:

• Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience

• BS in Engineering and previous experience in a medical device industry

• Experience with engineering processes and procedures.

• 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

• 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.

Red Flags:
No engineering degree/experience

Why is the Position Open?
Supplement to the team

Interview Process:
1 phone interview and 1 video call

We invite qualified candidates to send your resume to  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  You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
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