Engineer Senior Medical Device Root Cause Investigations JP13462
Engineer Senior Medical Device Root Cause Investigations JP13462
Posted on :
15-03-2025
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1 Vacancy
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Hourly Salary
$ 44 - 50
Vacancy
1 Vacancy
Posted on :
15-03-2025
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.
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;
Microinfuser delivery pump systems.
The qualified candidate will lead technical teams to ensure successful device development of these mechanical and electromechanical 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 crossfunctional organization to utilize technologies and methodologies that support shortcycle 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 crossfunctionally 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 electromechanical 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 youre not interested in pursuing this particular position please feel free to take a look at the other positions on our website www.3keyconsulting/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
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;
Microinfuser delivery pump systems.
The qualified candidate will lead technical teams to ensure successful device development of these mechanical and electromechanical 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 crossfunctional organization to utilize technologies and methodologies that support shortcycle 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 crossfunctionally 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 electromechanical 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 youre not interested in pursuing this particular position please feel free to take a look at the other positions on our website www.3keyconsulting/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Regards
3KC Talent Acquisition Team
Employment Type
Hourly
Key Skills
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