Job Description
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.
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 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.
