3 Key Consulting
Engineer Senior, Medical Device Root Cause Investigations
3 Key Consulting, Thousand Oaks, California, United States, 91362
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 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.
Regards,
3KC Talent Acquisition Team
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 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.
Regards,
3KC Talent Acquisition Team