Engineer Senior, Medical Device Root Cause Investigations; JP
Listed on 2026-06-28
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Engineering
Biomedical Engineer, Medical Device Industry, Quality Engineering
Location: Newbury Park
Engineer Senior, Medical Device Root Cause Investigations
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:
- 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
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